An interventional study of Best Practice and Quality-of-Life Assessment in Breast Carcinoma and Radiation-Induced Dermatitis, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-06-11.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Supportive care
This randomized pilot clinical trial studies how well topical keratin works in treating radiation dermatitis in patients with breast cancer. Radiation dermatitis is a skin condition that is a common side effect of radiation therapy. The affected skin becomes painful, red, itchy, and blistered. Topical keratin may help to improve skin appearance and hydration in patients with breast cancer.
PRIMARY OBJECTIVES:
I. To determine a preliminary estimate of the improvement of skin's natural barrier, decrease of dehydration, and reduction in the appearance of inflammation associated with radiation therapy (RT) skin toxicity as well as patients' satisfaction with their skin after the application of the medical device topical keratin (KeraStat Cream) during RT in breast cancer patients.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive topical keratin topically at least twice daily (BID) until the end of radiation therapy (approximately 3-6 weeks).
GROUP II: Patients receive standard of care as directed by radiation oncologist until the end of radiation therapy (approximately 3-6 weeks).
After completion of study treatment, patients are followed up at 4-6 weeks.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's enrollment of 25 is below the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive topical keratin topically at least BID until the end of radiation therapy (approximately 3-6 weeks).
Other: Quality-of-Life Assessment · Device: Topical Keratin
Patients receive standard of care as directed by radiation oncologist until the end of radiation therapy (approximately 3-6 weeks).
Other: Best Practice · Other: Quality-of-Life Assessment
Receive standard of care
Also known as: standard of care, standard therapy
Ancillary studies
Also known as: Quality of Life Assessment
Given topically
Also known as: KeraStat
Incidence of Early Adverse Skin Reactions (EASRs)
The Modified ONS Criteria for Radiation-Induced Acute Skin Toxicity will be used for classification of EASRs related to the skin. Participants will report in a total of 7 visits any experience with Grade I (faint or dull erythema; dry desquamation or Grade II (tender or bright erythema, patchy, moist desquamation) acute radiation dermatitis using the RTOG (Radiation Therapy Oncology Group) grading system with Grade II considered the worse outcome. Comparative effectiveness will include the number or study participants in each arm that experience RTOG Grade I or Grade II radiation dermatitis and moist desquamation.
Time frame: Up to 4 weeks post-RT
Change in Quality of Life
A 10-item assessment completed at each visit (7 total) to measure participant's Dermatology Life Quality Index. Score range is 0-3 (very much = 3; a lot = 2; a little = 1; and not at all or not relevant = 0) Maximum score of 30. The higher the score the more qualify of life is impaired. The average DQLI score at each study visit will be compared between the KeraStat® Cream arm and the SOC arm as a study effectiveness measure.
Time frame: Baseline to up to 7 weeks
Physician Observed Improvement in Skin Appearance
Skin appearance was assessed by the treating physician at each visit (total of 7) using the Radiation Therapy Oncology Group (RTOG) Toxicity scale Grade 1 and Grade 2 assessed only. Score = (Grade 1 (follicular, faint or dull erythema, dry desquamation and Grade 2 (tender or bright erythema, patchy, ,moist desquamation) with Grade 2 being the worst for this study. Scores range from 0 to 2, with higher values being the worst. The average RTOG score at each study visit will be compared between the KeraStat® Cream arm and the SOC arm as a study effectiveness measure.
Time frame: Baseline to up to 7 weeks
Number of Participants Reported Change in Skin Appearance Using the Dermatology Quality of Life Index Scale
Change in skin appearance by the participants' self-report using the Dermatology Quality of Life Index (DLQI) was used to assess skin after completion of radiation. Score range is 0-3 (very much = 3; a lot = 2; a little = 1; and not at all or not relevant = 0) Maximum score of 30. A higher score shows better performance/improvement in skin appearance. The average Dermatology Qualify of Life Index score each study visit will be compared between the two arms with the number of participants reporting a score.
Time frame: Baseline to up to 7 weeks
| Milestone | Group I (Topical Keratin) | Group II (Standard of Care) |
|---|---|---|
| Started | 13 | 12 |
| Completed | 13 | 11 |
| Not completed | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
The Modified ONS Criteria for Radiation-Induced Acute Skin Toxicity will be used for classification of EASRs related to the skin. Participants will report in a total of 7 visits any experience with Grade I (faint or dull erythema; dry desquamation or Grade II (tender or bright erythema, patchy, moist desquamation) acute radiation dermatitis using the RTOG (Radiation Therapy Oncology Group) grading system with Grade II considered the worse outcome. Comparative effectiveness will include the number or study participants in each arm that experience RTOG Grade I or Grade II radiation dermatitis and moist desquamation.
| Participants | Group I (Topical Keratin) | Group II (Standard of Care) |
|---|---|---|
| Grade I Acute Radiation Dermatitis | 13 | 10 |
| Grade II Acute Radiation Dermatitis | 4 | 6 |
| Moist Desquamation | 1 | 0 |
A 10-item assessment completed at each visit (7 total) to measure participant's Dermatology Life Quality Index. Score range is 0-3 (very much = 3; a lot = 2; a little = 1; and not at all or not relevant = 0) Maximum score of 30. The higher the score the more qualify of life is impaired. The average DQLI score at each study visit will be compared between the KeraStat® Cream arm and the SOC arm as a study effectiveness measure.
| score on a scale | Group I (Topical Keratin) | Group II (Standard of Care) |
|---|---|---|
| Visit 1 (baseline) | 0.31 ± 0.82 | 2.73 ± 5.26 |
| Visit 2 | 0.77 ± 1.31 | 1.64 ± 2.06 |
| Visit 3 | 2.23 ± 3.85 | 1.91 ± 2.11 |
| Visit 4 | 2.85 ± 2.98 | 2.36 ± 2.53 |
| Visit 5 | 4.75 ± 6.99 | 5.27 ± 5.01 |
| Visit 6 | 4.25 ± 4.87 | 6.18 ± 5.70 |
| Visit 7 | 0.85 ± 1.10 | 1.00 ± 2.05 |
Skin appearance was assessed by the treating physician at each visit (total of 7) using the Radiation Therapy Oncology Group (RTOG) Toxicity scale Grade 1 and Grade 2 assessed only. Score = (Grade 1 (follicular, faint or dull erythema, dry desquamation and Grade 2 (tender or bright erythema, patchy, ,moist desquamation) with Grade 2 being the worst for this study. Scores range from 0 to 2, with higher values being the worst. The average RTOG score at each study visit will be compared between the KeraStat® Cream arm and the SOC arm as a study effectiveness measure.
| units on a scale | Group I (Topical Keratin) | Group II (Standard of Care) |
|---|---|---|
| Visit 1 (baseline) | 0.00 ± 0 | 0.00 ± 0 |
| Visit 2 | 0.15 ± 0.36 | 0.09 ± 0.29 |
| Visit 3 | 0.62 ± 0.49 | 0.55 ± 0.50 |
| Visit 4 | 1.00 ± 0.68 | 0.82 ± 0.38 |
| Visit 5 | 1.17 ± 0.55 | 1.00 ± 0.43 |
| Visit 6 | 1.00 ± 0 | 1.36 ± 0.64 |
| Visit 7 | 0.23 ± 0.42 | 0.30 ± 0.46 |
Change in skin appearance by the participants' self-report using the Dermatology Quality of Life Index (DLQI) was used to assess skin after completion of radiation. Score range is 0-3 (very much = 3; a lot = 2; a little = 1; and not at all or not relevant = 0) Maximum score of 30. A higher score shows better performance/improvement in skin appearance. The average Dermatology Qualify of Life Index score each study visit will be compared between the two arms with the number of participants reporting a score.
| Participants | Group I (Topical Keratin) | Group II (Standard of Care) |
|---|---|---|
| Visit 1 (baseline) | 2 | 4 |
| Visit 2 | 6 | 6 |
| Visit 3 | 8 | 8 |
| Visit 4 | 11 | 7 |
| Visit 5 | 11 | 10 |
| Visit 6 | 10 | 10 |
| Visit 7 | 7 | 2 |
Collected over Up to 30 days post radiation therapy. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group I (Topical Keratin) | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Group II (Standard of Care) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Age, Continuous(Years) | Group I (Topical Keratin) | Group II (Standard of Care) | Total |
|---|---|---|---|
| Mean | 59.15 ± 9.5 | 65.36 ± 7.18 | 62.0 ± 9.3 |
| Sex: Female, Male(Participants) | Group I (Topical Keratin) | Group II (Standard of Care) | Total |
|---|---|---|---|
| Female | 13 | 11 | 24 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Group I (Topical Keratin) | Group II (Standard of Care) | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 13 | 11 | 24 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Group I (Topical Keratin) | Group II (Standard of Care) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 2 | 3 |
| White | 11 | 9 | 20 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Group I (Topical Keratin) | Group II (Standard of Care) | Total |
|---|---|---|---|
| United States | 13 | 11 | 24 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Mar 2018 to primary completion in Nov 2018, 7 months.
Results were first posted in Feb 2020, 1 year 3 months after primary completion.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's 7 months is below that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
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