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Biological
Platelet Rich Plasma for Genitourinary Syndrome in Breast Cancer Patients
Phase 1
Waitlist Available
Led By Anita H Chen, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Triple negative or HER2 positive breast cancer =< 3 years from initial diagnosis
Natural, surgical, or medically induced menopause
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 6 months
Awards & highlights
Study Summary
This trial is to test the possible benefits and side effects of platelet-rich plasma for treating menopause symptoms in breast cancer patients. Platelet-rich plasma is made by taking 4-6 tablespoons of blood from a patient's arm and spinning it in a centrifuge to separate the plasma and red blood cells. The platelet-rich plasma is then injected into the patient.
Who is the study for?
This trial is for women over 18 with stage 0-III breast cancer who've been in menopause naturally, surgically, or medically. They must be able to follow the treatment plan and complete questionnaires. Women can't join if they're using hormone therapy, have certain pelvic conditions, uncontrolled illnesses, a history of vulvovaginal issues or pelvic radiation, recent pelvic surgery, immune deficiencies like HIV on antiretroviral therapy, or specific blood count abnormalities.Check my eligibility
What is being tested?
The study tests platelet rich plasma (PRP) as a treatment for genitourinary syndrome of menopause symptoms in breast cancer patients. PRP is made from the patient's own blood and injected back into them. The trial includes quality-of-life assessments and questionnaire administration to evaluate benefits and side effects.See study design
What are the potential side effects?
Potential side effects are not detailed but may include discomfort at injection sites or allergic reactions to components used during PRP preparation such as lidocaine. As this is an investigational study, part of its purpose is to identify any additional side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is triple negative or HER2 positive and was diagnosed within the last 3 years.
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I have gone through menopause naturally, surgically, or due to medical treatment.
Select...
I am a woman aged 18 or older.
Select...
I experience vaginal discomfort such as itching, dryness, or pain during sex.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Tolerability of planned injection regimen with pain scores
Secondary outcome measures
Change in Day-to-Day Impact of Vaginal Aging score
Change in sexual function
Change in urinary symptoms
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment of GSM (platelet rich plasma)Experimental Treatment3 Interventions
Patients receive platelet rich plasma via injection into the vaginal area.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Therapeutic Autologous Platelet-rich Plasma
2020
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,206 Previous Clinical Trials
3,767,063 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,647 Total Patients Enrolled
Anita H Chen, MDPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My pelvic organ prolapse is more severe than stage II.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.My white blood cell count is either too low or too high.My blood's hematocrit level is either below 34.9% or above 44.9%.I have ongoing pelvic pain due to tight pelvic muscles.My breast cancer is triple negative or HER2 positive and was diagnosed within the last 3 years.My breast cancer is confirmed and has not come back.I have not used hormone replacement therapy in the last 3 months.I am HIV positive but not immunocompromised, or I am immunocompromised.I have gone through menopause naturally, surgically, or due to medical treatment.I haven't used vaginal moisturizers, lubricants, or homeopathic products in the last 2 weeks.My breast cancer is confirmed and is at stage 0 to III without recurrence for 3+ years if at stage III.I have a history of specific vulvovaginal conditions or treatments.You are allergic to silicone.You are allergic to lidocaine or prilocaine.I am a woman aged 18 or older.I have not had pelvic surgery in the last 6 months.My platelet count is either below 150 or above 450.My hemoglobin levels are not between 11.6 and 15.5 g/dL.I experience vaginal discomfort such as itching, dryness, or pain during sex.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment of GSM (platelet rich plasma)
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.
Genitourinary Syndrome Patient Testimony for trial: Trial Name: NCT04535323 — Phase 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Food and Drug Administration authorized platelet-rich plasma for medical use?
"With limited prior evidence of efficacy and safety, PRP was assigned a 1 on our team's scale."
Answered by AI
What is the ultimate ambition of this clinical experiment?
"This long-term trial is intended to evaluate the amount of adverse events caused by treatment, as well as changes from baseline in Vaginal and Vulvar Assessment Scale (VAS/VuAS), Vaginal Maturation Index (VMI) and Day-to-Day Impact of Vaginal Aging Questionnaire (DIVA). This assessment will span two years."
Answered by AI
Could you please provide an approximate figure of how many participants are involved in the experiment?
"Affirmative. The clinicaltrials.gov database points to this experiment still actively seeking recruits, which began on September 23rd 2020 and was most recently updated November 9th 2022. A total of 20 people are needed from one location for the trial's completion."
Answered by AI
Are there any remaining vacancies for test subjects in this research endeavor?
"Affirmative. The trial data on clinicialtrials.gov confirms that the medical study, which was first published on September 23rd 2020 is currently recruiting participants. Twenty patients need to be enrolled from a single site."
Answered by AI
Who else is applying?
What state do they live in?
Florida
Pennsylvania
How old are they?
65+
What site did they apply to?
Mayo Clinic in Florida
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I have pain and discomfort and I would like to find an effective treatment.
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
Email
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