A Phase 2 interventional study of Carbon Dioxide Fractional Laser and Questionnaire Administration in Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage IA Breast Cancer AJCC v8, sponsored by Mayo Clinic. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-06.
Sponsored by Mayo Clinic · Phase 2, Interventional, and Treatment
This phase II trial studies how well carbon dioxide fractional (CO2RE) laser works in treating participants with stage 0-III hormone receptor-positive breast cancer with vulvovaginal atrophy associated with dryness, inflammation or thinning of the epithelial lining of the vulva and vagina. CO2RE laser is a device that delivers controlled CO2 energy to the vaginal tissue and may help treat vaginal symptoms such as itching, burning, painful sexual intercourse, thickened or thin skin of the vulva, and stinging.
PRIMARY OBJECTIVES:
I. To evaluate the reduction in Vulvovaginal Symptom Questionnaire (VSQ) score at 3-month follow up after CO2RE laser treatment.
SECONDARY OBJECTIVES:
I. To evaluate the reduction in VSQ score after CO2RE laser treatment 6-month follow-up and 12-month follow-up.
II. To evaluate Female Sexual Function Index (FSFI) score before and after treatment with CO2RE laser.
III. To evaluate Urogenital Distress Inventory (UDI) 6 score before and after treatment with CO2RE laser.
IV. To evaluate vaginal health index score and vaginal caliber before and after treatment with CO2RE laser.
V. To evaluate discomfort and pain during CO2RE laser treatment using the visual analog scale.
VI. To evaluate treatment satisfaction after CO2RE laser treatment using 5-point Likert scale.
VII. To evaluate adherence to aromatase inhibitor at 6 and 12 months after CO2RE laser treatment.
EXPLORATORY OBJECTIVES:
I. To assess the change in the vaginal cytology using vaginal maturation index at baseline and during follow-up.
II. To assess serum estradiol level at baseline and after CO2RE laser treatment.
OUTLINE:
Participants undergo carbon dioxide fractional laser therapy over 10-15 minutes on day 1. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants are followed up at 3, 6, and 12 months.
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Exclusion Criteria:
Participants undergo carbon dioxide fractional laser therapy over 10-15 minutes on day 1. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Device: Carbon Dioxide Fractional Laser · Other: Questionnaire Administration
Undergo CO2RE laser therapy
Also known as: CO2 Fractional Laser
Ancillary studies
Reduction in Vulvovaginal Symptom Questionnaire (VSQ) (symptoms, emotions, and life-impact)
Descriptive statistics (mean, standard deviation \[SD\], median, interquartile range \[IQR\]) using frequency table and histogram will be used to summarize the reduction in the sum of VSQ total score first three scales of the VSQ (symptoms, emotions, and life-impact) at 3 months after treatment versus (vs.) baseline.
Time frame: Baseline up to 3 months
Reduction in VSQ score (symptoms, emotions, and life-impact)
Will evaluate the sum of first three scales of the VSQ (symptoms, emotions, and life impact), VSQ total scale, and sub-scales. Descriptive statistics (mean, SD, median, IQR) and longitudinal plots (raw value, change, change in percentage) will be used to summarize the sum of VSQ total score first three scales of the VSQ (symptoms, emotions, and life-impact), VSQ total scale and subscales.
Time frame: Baseline up to 12 months
Female Sexual Function Index (FSFI) score
Descriptive statistics (mean, SD, median, IQR) and will be used to summarize FSFI total score and subscales before and after treatment.
Time frame: Baseline up to 12 months
Urogenital Distress Inventory (UDI) 6 score
Descriptive statistics (mean, SD, median, IQR) and will be used to summarize UDI-6 score before and after treatment.
Time frame: Baseline up to 12 months
Vaginal health index score
Descriptive statistics (frequency table) and histogram will be used to summarize vaginal health index score before and after treatment.
Time frame: Baseline up to 12 months
Vaginal caliber
Descriptive statistics (mean, SD, median, IQR) and will be used to summarize vaginal caliber before and after treatment.
Time frame: Baseline up to 12 months
Discomfort and pain during carbon dioxide fractional (CO2RE) laser treatment using the visual analog scale
Descriptive statistics (mean, SD, median, IQR) and will be used to summarize the visual analogue pain scale during treatment.
Time frame: Up to 12 months
Treatment satisfaction as measured by 5-point Likert scale
Descriptive statistics (frequency table) and histogram will be used to summarize treatment satisfaction after CO2RE laser treatment using 5-point Likert scale during follow-up
Time frame: Up to 12 months
Adherence to aromatase inhibitor as measured by the Simplified Medication Adherence Questionnaire
Descriptive statistics (frequency table) and histogram will be used to summarize the Simplified Medication Adherence Questionnaire during follow-up.
Time frame: Up to 12 months
Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Time frame: Up to 12 months
Change in vaginal cytology using vaginal maturation index
Descriptive statistics (mean, SD, median, IQR) and longitudinal plots (raw value, change, change in percentage) will be used to summarize the change in the vaginal cytology using vaginal maturation index.
Time frame: Baseline up to 12 months
Assessment of serum estradiol levels
Descriptive statistics (mean, SD, median, IQR) and longitudinal plots (raw value, change, change in percentage) will be used to summarize serum estradiol level at baseline and after CO2RE laser treatment and the change from baseline.
Time frame: Baseline up to 12 months
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