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

Primary Purpose

Breast Cancer, Genitourinary Syndrome of Menopause

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Platelet-rich plasma (PRP)
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • University of MiamiRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Platelet-rich plasma (PRP) Group

Arm Description

Participants will undergo two sessions of platelet-rich plasma (PRP) injections to the vulva/vagina one month apart.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
March 31, 2023
Last Updated
September 27, 2023
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT05812924
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 26, 2023 (Actual)
Primary Completion Date
September 30, 2026 (Anticipated)
Study Completion Date
September 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Genitourinary Syndrome of Menopause

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Platelet-rich plasma (PRP) Group
Arm Type
Experimental
Arm Description
Participants will undergo two sessions of platelet-rich plasma (PRP) injections to the vulva/vagina one month apart.
Intervention Type
Biological
Intervention Name(s)
Platelet-rich plasma (PRP)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in GSM symptoms as measured by vulvovaginal symptom questionnaire (VSQ).
Description
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.
Time Frame
Baseline, up to 31 weeks
Secondary Outcome Measure Information:
Title
Change in Vaginal health index (VHI) Score
Description
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.
Time Frame
Baseline, up to 31 weeks
Title
Change in validated female sexual function index (FSFI)
Description
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.
Time Frame
Baseline, up to 31 weeks
Title
Change in sexual-related distress (FSDS-R).
Description
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.
Time Frame
Baseline, up to 31 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristin E. Rojas, MD
Phone
305-243-1450
Email
krojas@med.miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin E Rojas, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristin E. Rojas, MD
Phone
305-243-1450
Email
krojas@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Kristin E Rojas, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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