A Novel Therapy for Breast Cancer Survivors With Genitourinary Syndrome of Menopause
- Conditions
- Breast CancerGenitourinary Syndrome of Menopause
- Registration Number
- NCT05812924
- Lead Sponsor
- University of Miami
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 20
Inclusion Criteria:<br><br> - Female patients who are age 18 years and older<br><br> - Patients must have a history of biopsy-proven Ductal carcinoma in situ (DCIS) or<br> Stage I-III breast cancer and must be currently undergoing treatment or have<br> completed primary treatment.<br><br> - Patients must be found to have a vaginal health index (VHI) score of <15.<br><br> - Patients may be currently using endocrine therapy (ovarian function suppression,<br> tamoxifen, or aromatase inhibitors). Patients not currently using endocrine therapy<br> will also be eligible for participation since patients more than 5 or 10 years from<br> diagnosis (and therefore having completed adjuvant endocrine therapy) may be<br> enrolled.<br><br> - Some patients with triple negative breast cancer who receive chemotherapy also<br> experience GSM related to ovarian function decline outside of the setting of ovarian<br> suppression, and therefore patients with either ER+ or ER- breast cancer will be<br> allowed to participate.<br><br> - Patients must provide written informed consent for participation in this study.<br><br> - Patients are allowed to have used non-hormonal moisturizers but if they have<br> previously used hormonal moisturizers, they will be asked to stop the use for one<br> month prior to the first planned treatment, termed the washout period, if needed.<br><br>Exclusion Criteria:<br><br> - Patients with any systemic or topical hormone replacement therapy within 3 months<br> prior to enrollment, known genital infection, coagulation disorders, or on<br> anticoagulant therapy or turmeric-containing supplements within the prior 2 weeks<br> will be excluded.<br><br> - Women who are pregnant or who plan to become pregnant within the following six<br> months will be excluded since the impact of recent PRP injections to the vulva and<br> the impact on obstetric injury during vaginal delivery has not been studied.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in GSM symptoms as measured by vulvovaginal symptom questionnaire (VSQ).
- Secondary Outcome Measures
Name Time Method Change in Vaginal health index (VHI) Score;Change in validated female sexual function index (FSFI);Change in sexual-related distress (FSDS-R).