What side effects are associated with this type of intervention?

Platelet Rich Plasma (PRP) therapy, used for treating Genitourinary Syndrome, involves injecting concentrated platelets to promote tissue regeneration and healing. Known side effects of PRP therapy include pain at the injection site, infection, and tissue damage. Other common treatments for Genitourinary Syndrome, such as hormonal therapies, may cause side effects like breast tenderness, headaches, and mood changes. It is important to discuss potential risks and benefits with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several treatments for Genitourinary Syndrome of Menopause (GSM), primarily focusing on hormone replacement therapies such as estrogen creams, tablets, and rings that help alleviate symptoms by promoting tissue regeneration and maintaining vaginal health. Additionally, non-hormonal treatments like moisturizers and lubricants are commonly recommended. While PRP therapy, which promotes tissue regeneration through growth factors released by platelets, is being studied for its potential benefits in GSM, it has not yet received FDA approval specifically for this condition.

What other types of research exist?

One promising alternative to PRP for Genitourinary Syndrome patients is stem cell therapy. Stem cell therapy involves the use of stem cells to promote tissue regeneration and healing. Despite the lack of high-quality clinical trials, its popularity is growing due to its potential to meet clinical needs where established treatments are lacking. Another potential alternative is the use of autologous platelet concentrates (APC), which have shown some benefit in other medical conditions and may offer similar regenerative properties.

← Back to Search

Biological

Platelet Rich Plasma for Genitourinary Syndrome in Breast Cancer Patients

Q: What is the mechanism of action of this treatment?

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.

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

Select...

My breast cancer is triple negative or HER2 positive and was diagnosed within the last 3 years.

Select...

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 6 months

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

0 / 10Eligibility criteria met

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.