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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
Must not have
Pelvic organ prolapse greater than stage II
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if PRP, made from a patient's own blood, can help breast cancer patients with menopause-related symptoms. The treatment involves injecting concentrated platelets to promote healing and reduce symptoms like vaginal dryness and urinary issues.

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.
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.
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 below
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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.
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I am a woman aged 18 or older.
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I experience vaginal discomfort such as itching, dryness, or pain during sex.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My pelvic organ prolapse is more severe than stage II.
Select...
I do not have any serious illnesses or social situations that would stop me from following the study's requirements.
Select...
I have ongoing pelvic pain due to tight pelvic muscles.
Select...
I have not used hormone replacement therapy in the last 3 months.
Select...
I have a history of specific vulvovaginal conditions or treatments.
Select...
I have not had pelvic surgery in the last 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of adverse events
Tolerability of planned injection regimen with pain scores
Secondary study objectives
Change in Day-to-Day Impact of Vaginal Aging score
Change in sexual function
Change in urinary symptoms
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Platelet Rich Plasma (PRP) promotes tissue regeneration and healing through growth factors released by platelets, which is particularly beneficial for Genitourinary Syndrome patients. These growth factors help repair and rejuvenate atrophic and damaged tissues, alleviating symptoms like dryness, irritation, and discomfort. This mechanism enhances cellular proliferation and differentiation, potentially improving the overall quality of life for patients suffering from this condition.
[The efficiency of combination therapy of non-gonococcal urethritis in men].Treatment of Peyronie's Disease With Collagenase Clostridium histolyticum and Vacuum Therapy: A Randomized, Open-Label Pilot Study.Tanezumab Reduces Pain in Women with Interstitial Cystitis/Bladder Pain Syndrome and Patients with Nonurological Associated Somatic Syndromes.

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,318 Previous Clinical Trials
2,951,071 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,886 Previous Clinical Trials
41,020,939 Total Patients Enrolled
Anita H Chen, MDPrincipal InvestigatorMayo Clinic

Media Library

Therapeutic Autologous Platelet-rich Plasma (Biological) Clinical Trial Eligibility Overview. Trial Name: NCT04535323 — Phase 1
Genitourinary Syndrome Research Study Groups: Treatment of GSM (platelet rich plasma)
Genitourinary Syndrome Clinical Trial 2023: Therapeutic Autologous Platelet-rich Plasma Highlights & Side Effects. Trial Name: NCT04535323 — Phase 1
Therapeutic Autologous Platelet-rich Plasma (Biological) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04535323 — Phase 1
Genitourinary Syndrome Patient Testimony for trial: Trial Name: NCT04535323 — Phase 1
~4 spots leftby Oct 2025