Your session is about to expire
← Back to Search
Other
PRP Therapy for Genitourinary Syndrome in Breast Cancer Survivors
Phase 2
Recruiting
Led By Kristin E Rojas, MD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Female patients who are age 18 years and older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, up to 31 weeks
Awards & highlights
Study Summary
This trial will test if PRP injections help breast cancer patients with genitourinary symptoms due to menopause.
Who is the study for?
This trial is for female breast cancer survivors experiencing menopause symptoms in the genital area. They must be over 18, may be on or off endocrine therapy, and have a low vaginal health score. Women using hormones or with coagulation issues can't join.Check my eligibility
What is being tested?
The study tests if injecting platelet-rich plasma (PRP) into the vulva and vagina can relieve menopausal genital symptoms in breast cancer patients. It's seeing if this non-hormonal treatment is beneficial.See study design
What are the potential side effects?
Potential side effects of PRP injections might include pain at the injection site, infection risk, bleeding due to needle insertion, and possible allergic reactions to components of the PRP.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have or had early-stage breast cancer and am currently being treated or have finished treatment.
Select...
I am a woman aged 18 or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, up to 31 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, up to 31 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in GSM symptoms as measured by vulvovaginal symptom questionnaire (VSQ).
Secondary outcome measures
Change in Vaginal health index (VHI) Score
Change in sexual-related distress (FSDS-R).
Change in validated female sexual function index (FSFI)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Platelet-rich plasma (PRP) GroupExperimental Treatment1 Intervention
Participants will undergo two sessions of platelet-rich plasma (PRP) injections to the vulva/vagina one month apart.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Platelet-rich plasma (PRP)
2009
Completed Early Phase 1
~10
Find a Location
Who is running the clinical trial?
University of MiamiLead Sponsor
902 Previous Clinical Trials
410,056 Total Patients Enrolled
16 Trials studying Breast Cancer
1,531 Patients Enrolled for Breast Cancer
Kristin E Rojas, MDPrincipal InvestigatorUniversity of Miami
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have breast cancer that may be hormone receptor positive or negative.I have or had early-stage breast cancer and am currently being treated or have finished treatment.I have not used hormone therapy, had genital infections, blood clotting issues, or taken anticoagulants or turmeric supplements recently.I am currently using or have used endocrine therapy for my cancer.I am not pregnant and do not plan to become pregnant in the next six months.Your vaginal health index score must be less than 15.I have only used non-hormonal moisturizers or stopped hormonal ones for a month.I am a woman aged 18 or older.
Research Study Groups:
This trial has the following groups:- Group 1: Platelet-rich plasma (PRP) Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Platelet-rich plasma (PRP) Group attained regulatory clearance by the FDA?
"Due to limited efficacy data, our Power team assigned a safety rating of 2 for the Platelet-rich plasma (PRP) Group. This is because this study is in its second phase and has yet to demonstrate results supporting effectiveness."
Answered by AI
Is there an opportunity to enroll in this trial at the moment?
"According to clinicaltrials.gov, the recruitment for this medical trial has been halted as of March 31st 2023. Although it's not actively seeking candidates at present, there are several other trials that are still open with a total of 4067 active studies currently recruiting participants."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger