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

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
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• 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.

Locations
United States
Florida
University of Miami
RECRUITING
Miami
Contact Information
Primary
Kristin E. Rojas, MD
krojas@med.miami.edu
305-243-1450
Time Frame
Start Date: 2023-09-26
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 20
Treatments
Experimental: Platelet-rich plasma (PRP) Group
Participants will undergo two sessions of platelet-rich plasma (PRP) injections to the vulva/vagina one month apart.
Related Therapeutic Areas
Sponsors
Leads: University of Miami

This content was sourced from clinicaltrials.gov

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