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

University of Miami

Status and phase

Active, not recruiting

Phase 2

Conditions

Breast Cancer

Genitourinary Syndrome of Menopause

Treatments

Biological: Platelet-rich plasma (PRP)

Study type

Interventional

Funder types

Other

Identifiers

NCT05812924

20221120

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.