A Phase 2 interventional study of Fluocinonide Cream and Management of Therapy Complications in Breast Carcinoma, sponsored by OHSU Knight Cancer Institute. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-09.
Sponsored by OHSU Knight Cancer Institute · Phase 2, Interventional, and Supportive care
This phase II trial studies how well giving fluocinonide cream works in treating symptoms of vaginal dryness and painful sexual intercourse in patients with breast cancer undergoing hormone therapy. Fluocinonide cream may prevent or lessen vaginal dryness and painful sexual intercourse in patients undergoing hormone therapy.
PRIMARY OBJECTIVES:
I. To estimate the decrease in symptoms of vaginal dryness and dyspareunia with the use of fluocinonide 0.05% cream in breast cancer subjects and subjects at increased risk for breast cancer on endocrine therapy. Estimates of decrease will be obtained utilizing patient survey instruments.
SECONDARY OBJECTIVES:
I. To estimate the decrease in symptoms of vaginal itching and the total vaginal index score with the use of fluocinonide 0.05% cream in breast cancer subjects and subjects at increased risk for breast cancer on endocrine therapy. Estimates of decrease will be obtained utilizing patient survey instruments.
II. To explore toxicities reported by subjects using fluocinonide 0.05% cream via vaginal application.
III. To explore correlation between subject reported compliance, as well as compliance via measurement of the amount of fluocinonide 0.05% cream used, and response rates with the use of fluocinonide 0.05% cream.
IV. To explore the correlations between patient characteristics and response rates with the use of fluocinonide 0.05% cream.
OUTLINE:
Patients apply topical fluocinonide cream twice daily (BID) in weeks 1-2 and once daily (QD) in weeks 3-4.
12,547 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 34 is below the median of 72 across 9,305 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →OHSU Knight Cancer Institute is the lead sponsor of 242 studies on the registry; 45 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 15 (56%) have results posted.
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Exclusion Criteria:
Patients apply topical fluocinonide cream BID in weeks 1-2 and QD in weeks 3-4.
Drug: Fluocinonide Cream · Procedure: Management of Therapy Complications · Other: Questionnaire Administration
Given topically
Also known as: fluocinonide, Lidex, Vanos
Receive fluocinonide cream
Also known as: complications of therapy, management of
Ancillary studies
Change in Symptom Scores of Vaginal Dryness
Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively). Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints. Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time frame: Baseline and 4 weeks
Change in Symptom Scores of Dyspareunia
Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively). Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints. Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time frame: Baseline and 4 weeks
Change in Symptom Scores of Vaginal Itching
Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively). Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-secondary endpoints. Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time frame: Baseline and 4 weeks
Change in Total Vaginal Index Score.
Change in total vaginal index score. The total vaginal index score is a numerical value ranging from zero to twelve, comprised of the three components of vaginal dryness, vaginal itching, and dyspareunia graded on an ordinal scale of zero to four added together. Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -12 to +12; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-secondary endpoints.
Time frame: Baseline and 4 weeks
Number of Patients Experiencing Toxicities
Toxicity data will be reported as descriptive data as the percentage of patients experiencing reported side effects. Toxicity and safety analyses will be conducted using the safety analysis set.
Time frame: Over 4 weeks
Change in Vaginal Dryness Symptom Scores by Age Characteristics
Association of response in symptoms with characteristics of the subject population (Dryness and Age) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time frame: Baseline and 4 weeks
Change in Dyspareunia Symptom Scores by Age Characteristics
Association of response in symptoms with characteristics of the subject population (Dyspareunia and Age) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time frame: Baseline and 4 weeks
Change in Vaginal Itching Symptom Scores by Age Characteristics
Association of response in symptoms with characteristics of the subject population (Itching and Age) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time frame: Baseline and 4 weeks
Change in Vaginal Dryness Symptom Scores by Menopause Status Characteristics
Association of response in symptoms with characteristics of the subject population (Dryness and Menopause status) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time frame: Baseline and 4 weeks
Change in Dyspareunia Symptom Scores by Menopause Status Characteristics
Association of response in symptoms with characteristics of the subject population (Dyspareunia and Menopause status) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time frame: Baseline and 4 weeks
Change in Vaginal Itching Symptom Scores by Menopause Status Characteristics
Association of response in symptoms with characteristics of the subject population (Itching and Menopause status) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time frame: Baseline and 4 weeks
Change in Vaginal Dryness Symptom Scores by Current Endocrine Therapy Characteristics
Association of response in symptoms with characteristics of the subject population (Dryness and current endocrine therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time frame: Baseline and 4 weeks
Change in Dyspareunia Symptom Scores by Current Endocrine Therapy Characteristics
Association of response in symptoms with characteristics of the subject population (Dyspareunia and current endocrine therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time frame: Baseline and 4 weeks
Change in Vaginal Itching Symptom Scores by Current Endocrine Therapy Characteristics
Association of response in symptoms with characteristics of the subject population (Itching and current endocrine therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time frame: Baseline and 4 weeks
Change in Vaginal Dryness Symptom Scores by Prior Cytotoxic Therapy Characteristics
Association of response in symptoms with characteristics of the subject population (Dryness and prior cytotoxic therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time frame: Baseline and 4 weeks
Change in Dyspareunia Symptom Scores by Prior Cytotoxic Therapy Characteristics
Association of response in symptoms with characteristics of the subject population (Dyspareunia and prior cytotoxic therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time frame: Baseline and 4 weeks
Change in Vaginal Itching Symptom Scores by Prior Cytotoxic Therapy Characteristics
Association of response in symptoms with characteristics of the subject population (Itching and prior cytotoxic therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time frame: Baseline and 4 weeks
Change in Vaginal Dryness Symptom Scores by Indication for Endocrine Therapy Characteristics
Association of response in symptoms with characteristics of the subject population (Dryness and Indications) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time frame: Baseline and 4 weeks
Change in Dyspareunia Symptom Scores by Indication for Endocrine Therapy Characteristics
Association of response in symptoms with characteristics of the subject population (Dyspareunia and Indications) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time frame: Baseline and 4 weeks
Change in Vaginal Itching Symptom Scores by Indication for Endocrine Therapy Characteristics
Association of response in symptoms with characteristics of the subject population (Itching and Indications) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time frame: Baseline and 4 weeks
Change in Vaginal Dryness Symptom Scores by Patient Reported Compliance Characteristics
Association of response in symptoms with patient reported compliance (Dryness) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with patient reported compliance. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Groups are made by % of compliance reported by patients
Time frame: Baseline and 4 weeks
Change in Dyspareunia Symptom Scores by Patient Reported Compliance Characteristics
Association of response in symptoms with patient reported compliance (Dyspareunia) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with patient reported compliance. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Groups are made by % of compliance reported by patients
Time frame: Baseline and 4 weeks
Change in Vaginal Itching Symptom Scores by Patient Reported Compliance Characteristics
Association of response in symptoms with patient reported compliance (Itching) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with patient reported compliance. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Groups are made by % of compliance reported by patients
Time frame: Baseline and 4 weeks
Change in Vaginal Dryness Symptom Scores by Tube Weight Based Compliance Characteristics
Association of response in symptoms with tube weight based compliance (Dryness) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with compliance determined by % of tube used by weight. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Groups are made by % of tube used by weight.
Time frame: Baseline and 4 weeks
Change in Dyspareunia Symptom Scores by Tube Weight Based Compliance Characteristics
Association of response in symptoms with tube weight based compliance (Dyspareunia) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with compliance determined by % of tube used by weight. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Groups are made by % of tube used by weight.
Time frame: Baseline and 4 weeks
Change in Vaginal Itching Symptom Scores by Tube Weight Based Compliance Characteristics
Association of response in symptoms with tube weight based compliance (Itching) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with compliance determined by % of tube used by weight. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Groups are made by % of tube used by weight.
Time frame: Baseline and 4 weeks
| Milestone | Supportive Care (Fluocinonide Cream) |
|---|---|
| Started | 34 |
| Completed | 30 |
| Not completed | 4 |
| Withdrew: Adverse event | 1 |
| Withdrew: Withdrawal by subject | 3 |
Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively). Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints. Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
| units on a scale | Supportive Care (Fluocinonide Cream) |
|---|---|
| Change in Symptom Scores of Vaginal Dryness | -2 (-3 to -1) |
Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively). Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints. Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
| units on a scale | Supportive Care (Fluocinonide Cream) |
|---|---|
| Change in Symptom Scores of Dyspareunia | -2 (-3 to -1.8) |
Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively). Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-secondary endpoints. Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
| units on a scale | Supportive Care (Fluocinonide Cream) |
|---|---|
| Change in Symptom Scores of Vaginal Itching | -1 (-2 to 0) |
Change in total vaginal index score. The total vaginal index score is a numerical value ranging from zero to twelve, comprised of the three components of vaginal dryness, vaginal itching, and dyspareunia graded on an ordinal scale of zero to four added together. Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -12 to +12; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-secondary endpoints.
| units on a scale | Supportive Care (Fluocinonide Cream) |
|---|---|
| Change in Total Vaginal Index Score. | -5 (-6 to -3.8) |
Toxicity data will be reported as descriptive data as the percentage of patients experiencing reported side effects. Toxicity and safety analyses will be conducted using the safety analysis set.
| Participants | Supportive Care (Fluocinonide Cream) |
|---|---|
| Number of Patients Experiencing Toxicities | 1 |
Association of response in symptoms with characteristics of the subject population (Dryness and Age) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
| units on a scale | Supportive Care (Fluocinonide Cream) |
|---|---|
| Age 18-45 | -1.5 (-2.5 to -1.0) |
| Age 46-55 | -2.0 (-3.0 to -2.0) |
| Age 56-65 | -2.0 (-2.0 to -1.5) |
| Age > 65 | -2.0 (-3.0 to -0.75) |
Association of response in symptoms with characteristics of the subject population (Dyspareunia and Age) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
| units on a scale | Supportive Care (Fluocinonide Cream) |
|---|---|
| Age 18-45 | -1 (-1 to -1) |
| Age 46-55 | -2 (-2 to -2) |
| Age 56-65 | -2.5 (-3 to -1.75) |
| Age > 65 | -3 (-3 to -3) |
Association of response in symptoms with characteristics of the subject population (Itching and Age) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
| units on a scale | Supportive Care (Fluocinonide Cream) |
|---|---|
| Age 18-45 | -0.5 (-1.25 to 0.25) |
| Age 46-55 | -1 (-2 to 0) |
| Age 56-65 | -1 (-1.75 to 0) |
| Age > 65 | -0.5 (-1.25 to 0) |
Association of response in symptoms with characteristics of the subject population (Dryness and Menopause status) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
| units on a scale | Supportive Care (Fluocinonide Cream) |
|---|---|
| Pre-Menopause | -2 (-2 to -2) |
| Post-menopause | -2 (-3 to -1) |
Association of response in symptoms with characteristics of the subject population (Dyspareunia and Menopause status) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
| units on a scale | Supportive Care (Fluocinonide Cream) |
|---|---|
| Pre-Menopause | NA (NA to NA) |
| Post-menopause | -2 (-3 to -1.75) |
Association of response in symptoms with characteristics of the subject population (Itching and Menopause status) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
| units on a scale | Supportive Care (Fluocinonide Cream) |
|---|---|
| Pre-Menopause | -1 (-1 to -1) |
| Post-menopause | -1 (-2 to 0) |
Association of response in symptoms with characteristics of the subject population (Dryness and current endocrine therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
| units on a scale | Supportive Care (Fluocinonide Cream) |
|---|---|
| Anastrazole | -2 (-2.75 to -2.0) |
| Exemestane | -2 (-2.5 to -1.5) |
| Letrozole | -2 (-3 to -1) |
| Tamoxifen | -2 (-2 to -1.25) |
Association of response in symptoms with characteristics of the subject population (Dyspareunia and current endocrine therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
| units on a scale | Supportive Care (Fluocinonide Cream) |
|---|---|
| Anastrazole | -2 (-2.5 to -1.5) |
| Exemestane | -2 (-2 to -2) |
| Letrozole | -2.5 (-3 to -2) |
| Tamoxifen | -1.5 (-1.75 to -1.25) |
Association of response in symptoms with characteristics of the subject population (Itching and current endocrine therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
| units on a scale | Supportive Care (Fluocinonide Cream) |
|---|---|
| Anastrazole | -0.5 (-1 to 0) |
| Exemestane | -1 (-1.5 to -0.5) |
| Letrozole | -0.5 (-2 to 0) |
| Tamoxifen | -1 (-1.75 to -1) |
Association of response in symptoms with characteristics of the subject population (Dryness and prior cytotoxic therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
| units on a scale | Supportive Care (Fluocinonide Cream) |
|---|---|
| Yes | -2 (-2 to -1) |
| No | -2 (-3 to -1) |
Association of response in symptoms with characteristics of the subject population (Dyspareunia and prior cytotoxic therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
| units on a scale | Supportive Care (Fluocinonide Cream) |
|---|---|
| Yes | -2 (-2.25 to -1) |
| No | -2.5 (-3 to -2) |
Association of response in symptoms with characteristics of the subject population (Itching and prior cytotoxic therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
| units on a scale | Supportive Care (Fluocinonide Cream) |
|---|---|
| Yes | -1 (-1 to 0) |
| No | -1 (-2 to 0) |
Association of response in symptoms with characteristics of the subject population (Dryness and Indications) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
| units on a scale | Supportive Care (Fluocinonide Cream) |
|---|---|
| Adjuvant | -2 (-2.5 to -1) |
| Prophylaxis | -3 (-3 to -3) |
Association of response in symptoms with characteristics of the subject population (Dyspareunia and Indications) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
| units on a scale | Supportive Care (Fluocinonide Cream) |
|---|---|
| Adjuvant | -2 (-3 to -1.75) |
| Prophylaxis | NA (NA to NA) |
Association of response in symptoms with characteristics of the subject population (Itching and Indications) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
| units on a scale | Supportive Care (Fluocinonide Cream) |
|---|---|
| Adjuvant | -1 (-1.75 to 0) |
| Prophylaxis | -2 (-2 to -2) |
Association of response in symptoms with patient reported compliance (Dryness) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with patient reported compliance. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Groups are made by % of compliance reported by patients
| units on a scale | Supportive Care (Fluocinonide Cream) |
|---|---|
| 50 - 74% | -2 (-2 to -2) |
| >= 75% | -2 (-3 to -1) |
| Missing / not reported | NA (NA to NA) |
Association of response in symptoms with patient reported compliance (Dyspareunia) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with patient reported compliance. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Groups are made by % of compliance reported by patients
| units on a scale | Supportive Care (Fluocinonide Cream) |
|---|---|
| 50 - 74% | NA (NA to NA) |
| >= 75% | -2 (-3 to -1.75) |
| Missing / not reported | NA (NA to NA) |
Association of response in symptoms with patient reported compliance (Itching) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with patient reported compliance. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Groups are made by % of compliance reported by patients
| units on a scale | Supportive Care (Fluocinonide Cream) |
|---|---|
| 50 - 74% | -1 (-1 to -1) |
| >= 75% | -1 (-2 to 0) |
| Missing / not reported | NA (NA to NA) |
Association of response in symptoms with tube weight based compliance (Dryness) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with compliance determined by % of tube used by weight. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Groups are made by % of tube used by weight.
| units on a scale | Supportive Care (Fluocinonide Cream) |
|---|---|
| < 25% | -1 (-1 to -1) |
| 25 - 49% | -2 (-3 to -1.75) |
| 50 - 74% | -2 (-3 to -1.75) |
| >= 75% | -2 (-2 to -2) |
| Missing / not reported | -2.5 (-3.25 to -1.75) |
Association of response in symptoms with tube weight based compliance (Dyspareunia) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with compliance determined by % of tube used by weight. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Groups are made by % of tube used by weight.
| units on a scale | Supportive Care (Fluocinonide Cream) |
|---|---|
| < 25% | -1 (-1 to -1) |
| 25 - 49% | -2 (-2.5 to -1.5) |
| 50 - 74% | -2 (-2.25 to -1.75) |
| >= 75% | -2 (-2.25 to -2) |
| Missing / not reported | -3 (-3 to -3) |
Association of response in symptoms with tube weight based compliance (Itching) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with compliance determined by % of tube used by weight. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Groups are made by % of tube used by weight.
| units on a scale | Supportive Care (Fluocinonide Cream) |
|---|---|
| < 25% | -1 (-1 to -1) |
| 25 - 49% | -1 (-2 to 0) |
| 50 - 74% | 0 (-1 to 0) |
| >= 75% | -1 (-2 to -0.5) |
| Missing / not reported | -1 (-1.5 to -0.5) |
Collected over End of study week 1, 2, 3, 4. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Supportive Care (Fluocinonide Cream) | 0/34 (0%) | 0/34 (0%) | 24/34 (70.6%) |
| Event | Supportive Care (Fluocinonide Cream) |
|---|---|
| Pain of skinSkin and subcutaneous tissue disorders | 23/34 |
| Vaginal dischargeSkin and subcutaneous tissue disorders | 2/34 |
| Bullous dermatitisSkin and subcutaneous tissue disorders | 1/34 |
| FlushingSkin and subcutaneous tissue disorders | 1/34 |
| HeadacheGeneral disorders | 1/34 |
| PruritisSkin and subcutaneous tissue disorders | 1/34 |
| Rash acneiformSkin and subcutaneous tissue disorders | 1/34 |
| Vaginal inflammationSkin and subcutaneous tissue disorders | 1/34 |
An intent-to-treat analysis set will include those who are enrolled in the trial regardless of the number of treatments received. All primary analyses will be conducted using the intent-to-treat analysis set. A safety analysis set will include those who receive at least one treatment.
| Age, Categorical(Participants) | Supportive Care |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 29 |
| >=65 years | 5 |
| Age, Continuous(years) | Supportive Care |
|---|---|
| Mean | 55.44 ± 9.39 |
| Sex: Female, Male(Participants) | Supportive Care |
|---|---|
| Female | 34 |
| Male | 0 |
| Menopause status(Participants) | Supportive Care |
|---|---|
| Pre-menopausal | 1 |
| Post-menopausal | 33 |
| Current endocrine therapy(Participants) | Supportive Care |
|---|---|
| Anastrazole | 7 |
| Exemestane | 3 |
| Letrozole | 13 |
| Tamoxifen | 11 |
| Prior cytotoxic chemotherapy received(Participants) | Supportive Care |
|---|---|
| Prior cytotoxic chemotherapy | 14 |
| No prior cytotoxic chemotherapy | 20 |
| Indications for endocrine therapy(Participants) | Supportive Care |
|---|---|
| Adjuvant | 33 |
| Prophylaxis | 1 |
| Severe baseline symptoms, Dryness(Participants) | Supportive Care |
|---|---|
| Severe | 15 |
| Not severe | 19 |
2 further baseline measures are reported on the registry.
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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OHSU Knight Cancer Institute