A Novel Therapy for Breast Cancer Survivors With Genitourinary Syndrome of Menopause

Launched by UNIVERSITY OF MIAMI · Mar 31, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment for breast cancer survivors who are experiencing genitourinary syndrome of menopause (GSM), which can cause discomfort and other issues in the vaginal area. The study will look at whether injections of platelet rich plasma (PRP), which is derived from the patient’s own blood, can help improve these symptoms. The trial is currently recruiting female participants aged 18 and older who have had breast cancer and are either undergoing or have completed treatment. To qualify, participants must have a specific score indicating vaginal health that is below a certain level.

If you join the study, you can expect to receive PRP injections to the vulva and vagina, which may help alleviate your symptoms related to GSM. It's important to note that if you've recently used hormone treatments or have certain medical conditions, you may not be eligible for this trial. Additionally, women who are pregnant or planning to become pregnant in the next six months are excluded from participation. Overall, the goal of this study is to find a potentially effective way to improve the quality of life for breast cancer survivors dealing with these menopause-related issues.

Gender

FEMALE

Eligibility criteria

• 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 supplements within the prior 2 weeks will be excluded.
• • Women who are pregnant or who plan to become pregnant within the following six months will be excluded since the impact of recent PRP injections to the vulva and the impact on obstetric injury during vaginal delivery has not been studied.