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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Genitourinary Syndrome of Menopause
• Intervention / Treatment: Biological: Platelet-rich plasma (PRP)

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Kristin E. Rojas, MD; Phone Number: 305-243-1450; Email: krojas@med.miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
      • Contact: Kristin E. Rojas, MD; Phone Number: 305-243-1450; Email: krojas@med.miami.edu
      • Principal Investigator: Kristin E Rojas, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Platelet-rich plasma (PRP) Group; Participants will undergo two sessions of platelet-rich plasma (PRP) injections to the vulva/vagina one month apart.	Biological: Platelet-rich plasma (PRP); 0.1-0.2 mL injections of platelet-rich plasma (PRP) will be injected to the vulvovaginal area. The injections will be placed every 5mm and at an angle of 60° into the mucosa and lamina propria of the posterior wall of the vagina.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in GSM symptoms as measured by vulvovaginal symptom questionnaire (VSQ).	The VSQ is a 21-question survey that specifically asks about GSM symptoms and their impact on quality of life and sexual function. Vaginal and vulvar symptoms will be self-reported using validated VSQ modified to 4-point Likert scores. VSQ consists of a series of questions, each of which is rated as 0 (never), 1(rarely), 2(sometimes), 3 (frequently). Lower scores indicate better health. Each question is analyzed separately; there is no overall score reported.	Baseline, up to 31 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Vaginal health index (VHI) Score	VHI assesses post menopausal symptoms such as dryness, burning, and irritation. Each component is scored on a scale of 1 (worst) to 5 (best). Lower scores indicate more severe atrophy.	Baseline, up to 31 weeks
Change in validated female sexual function index (FSFI)	Change in validated female sexual function index (FSFI) is determined by the participant response to the female sexual function index (FSFI) questionnaire. The FSFI is a questionnaire competed by the participant and is designed to measure sexual functioning by assessing six areas of sexual function: desire, arousal, lubrication, orgasm, satisfaction, and pain. Scores range from 2 to 36. Higher scores indicate better sexual function.	Baseline, up to 31 weeks
Change in sexual-related distress (FSDS-R).	Change in validated female sexual distress is determined by participant response to the female sexual distress survey-revised (FSDS-R). The FSDS-R is a self reported questionnaire that asks participants to rate distress related to low sexual desire. Responses to the items on the Likert-type scale consist of never (0), rarely (1), sometimes (2), often (3), or always (4). The lowest score that can be obtained from the FSDS-R is "0" and the highest score is "52". Higher scores indicate higher levels of sexual distress.	Baseline, up to 31 weeks

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Kristin E Rojas, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: March 31, 2023
• First Submitted That Met QC Criteria: March 31, 2023
• First Posted (Actual): April 14, 2023

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Neoplasms by Site; Disease; Breast Diseases; Syndrome; Breast Neoplasms
• Other Study ID Numbers: 20221120

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No