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Trial Title:
A Novel Therapy for Breast Cancer Survivors With Genitourinary Syndrome of Menopause
NCT ID:
NCT05812924
Condition:
Breast Cancer
Genitourinary Syndrome of Menopause
Conditions: Official terms:
Breast Neoplasms
Syndrome
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Platelet-rich plasma (PRP)
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.
Arm group label:
Platelet-rich plasma (PRP) Group
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.
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Miami
Address:
City:
Miami
Zip:
33136
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kristin E. Rojas, MD
Phone:
305-243-1450
Email:
krojas@med.miami.edu
Investigator:
Last name:
Kristin E Rojas, MD
Email:
Principal Investigator
Start date:
September 26, 2023
Completion date:
September 30, 2026
Lead sponsor:
Agency:
University of Miami
Agency class:
Other
Source:
University of Miami
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05812924
