A Novel Therapy for Breast Cancer Survivors With Genitourinary Syndrome of Menopause (NCT05812924) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Novel Therapy for Breast Cancer Survivors With Genitourinary Syndrome of Menopause
United States18 participantsStarted 2023-09-26
Plain-language summary
The purpose of this study is to determine whether platelet rich plasma (PRP) injections to the vulva and vagina will improve symptoms of genitourinary syndrome of menopause (GSM) in breast cancer patients.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* Female patients who are age 18 years and older
* Patients must have a history of biopsy-proven Ductal carcinoma in situ (DCIS) or Stage I-III breast cancer and must be currently undergoing treatment or have completed primary treatment.
* Patients must be found to have a vaginal health index (VHI) score of \<15.
* Patients may be currently using endocrine therapy (ovarian function suppression, tamoxifen, or aromatase inhibitors). Patients not currently using endocrine therapy will also be eligible for participation since patients more than 5 or 10 years from diagnosis (and therefore having completed adjuvant endocrine therapy) may be enrolled.
* Some patients with triple negative breast cancer who receive chemotherapy also experience GSM related to ovarian function decline outside of the setting of ovarian suppression, and therefore patients with either ER+ or ER- breast cancer will be allowed to participate.
* Patients must provide written informed consent for participation in this study.
* Patients are allowed to have used non-hormonal moisturizers but if they have previously used hormonal moisturizers, they will be asked to stop the use for one month prior to the first planned treatment, termed the "washout period", if needed.
Exclusion Criteria:
* Patients with any systemic or topical hormone replacement therapy within 3 months prior to enrollment, known genital infection, coagulation disorders, or on anticoagulant therapy or turmeric-containing su…
What they're measuring
1
Change in GSM symptoms as measured by vulvovaginal symptom questionnaire (VSQ).