Clinical trial NCT05812924: A Novel Therapy for Breast Cancer Survivors With Genitourinary Syndrome of Menopause
Official title: A Novel Therapy for Breast Cancer Survivors With Genitourinary Syndrome of Menopause
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Breast Cancer
Genitourinary Syndrome of Menopause
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2023-04-14
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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 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.

Primary outcomes:
measure: Change in GSM symptoms as measured by vulvovaginal symptom questionnaire (VSQ).
timeFrame: Baseline, up to 31 weeks
Secondary outcomes:
measure: Change in Vaginal health index (VHI) Score
timeFrame: Baseline, up to 31 weeks
measure: Change in validated female sexual function index (FSFI)
timeFrame: Baseline, up to 31 weeks
measure: Change in sexual-related distress (FSDS-R).
timeFrame: Baseline, up to 31 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Kristin E Rojas, MD
role: PRINCIPAL_INVESTIGATOR
References: