PRP Therapy for Genitourinary Syndrome in Breast Cancer Survivors

Overseen By Kristin E Rojas, MD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: University of Miami

Must not be taking: Hormone therapy, Anticoagulants

Disqualifiers: Genital infection, Coagulation disorders, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether platelet-rich plasma (PRP) injections can relieve symptoms of genitourinary syndrome of menopause (GSM) in women who have had breast cancer. GSM can cause discomfort in the vulva and vagina, affecting daily life. The trial includes two PRP injection sessions one month apart. Women treated for breast cancer who experience GSM symptoms might be suitable for this study. Participants must not have recently used hormone replacement therapy and must provide consent to join. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but if you have used hormonal moisturizers, you must stop them for one month before starting the treatment. Also, you cannot be on hormone replacement therapy, anticoagulant therapy, or turmeric supplements shortly before joining the trial.

Is there any evidence suggesting that platelet-rich plasma (PRP) therapy is likely to be safe for humans?

Research has shown that platelet-rich plasma (PRP) injections are generally safe and well-tolerated. Made from the patient's own blood, PRP has proven effective in various medical areas, including bone and joint health, skin care, and women's health. For genitourinary syndrome of menopause (GSM), PRP injections have demonstrated safety and practicality. Specifically, one study found PRP to be a safe and simple treatment for postmenopausal vulvovaginal atrophy, which involves the thinning and drying of the vaginal walls. This suggests PRP could be a safe option for treating GSM in breast cancer survivors. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Platelet-rich plasma (PRP) therapy is unique because it uses components from a patient's own blood to promote healing and tissue regeneration in the vulva/vagina. Unlike the standard treatments for genitourinary syndrome, such as topical estrogen or lubricants, PRP offers a natural alternative by leveraging the body's own growth factors. Researchers are excited about PRP because it targets the underlying tissue repair mechanisms, potentially offering a more effective and longer-lasting solution for breast cancer survivors who can't use hormone-based treatments.

What evidence suggests that PRP therapy might be an effective treatment for genitourinary syndrome in breast cancer survivors?

Research has shown that platelet-rich plasma (PRP) injections might help ease symptoms of genitourinary syndrome of menopause (GSM) in breast cancer survivors. Studies have found that PRP can improve issues like vaginal dryness and pain during sex. One study found that a single PRP treatment was safe and feasible for patients. Another study suggested that PRP effectively treats GSM symptoms. The evidence indicates that PRP could be a promising option for improving the quality of life in these patients. Participants in this trial will undergo two sessions of PRP injections to the vulva/vagina, spaced one month apart, to further evaluate its effectiveness. ^{3 6 7 8 9}

Who Is on the Research Team?

Kristin E Rojas, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

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.

Inclusion 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 am currently using or have used endocrine therapy for my cancer.

Exclusion Criteria

I have not used hormone therapy, had genital infections, blood clotting issues, or taken anticoagulants or turmeric supplements recently.

I am not pregnant and do not plan to become pregnant in the next six months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo two sessions of platelet-rich plasma (PRP) injections to the vulva/vagina one month apart

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for changes in GSM symptoms and sexual function

27 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Platelet-rich plasma (PRP)

Trial Overview 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.

How Is the Trial Designed?

Group I: Platelet-rich plasma (PRP) Group Experimental Treatment 1 Intervention

Participants will undergo two sessions of platelet-rich plasma (PRP) injections to the vulva/vagina one month apart.

Platelet-rich plasma (PRP) is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Platelet-rich plasma for:

• Orthopedic conditions
• Wound care
• Dermatological conditions
• Hair restoration

Approved in Canada as Platelet-rich plasma for:

• Orthopedic conditions
• Wound care
• Dermatological conditions

Approved in European Union as Platelet-rich plasma for:

• Orthopedic conditions
• Wound care
• Dermatological conditions

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Published Research Related to This Trial

A systematic review of nine randomized controlled trials involving 325 participants found no significant difference in the healing of chronic wounds when comparing autologous platelet-rich plasma (PRP) to standard treatments or placebo.

While some results showed a higher percentage of wound area healed with PRP in mixed chronic wounds, overall evidence does not support the efficacy of PRP for chronic wound treatment, highlighting the need for more robust clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous platelet-rich plasma for treating chronic wounds. Martinez-Zapata, MJ., Martí-Carvajal, AJ., Solà, I., et al.[2022]

Autologous platelet-rich plasma (PRP) may help improve the healing of foot ulcers in people with diabetes, but this is based on low-quality evidence from only two small studies involving 189 participants.

Overall, the effectiveness of PRP for treating chronic wounds remains unclear, as the majority of studies show low-quality evidence and are underpowered, highlighting the need for more robust clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous platelet-rich plasma for treating chronic wounds. Martinez-Zapata, MJ., Martí-Carvajal, AJ., Solà, I., et al.[2022]

Platelet-rich plasma (PRP) is derived from a patient's own blood and contains a high concentration of platelets, which can enhance tissue regeneration.

PRP has shown effectiveness in treating various types of hair loss, including androgenic alopecia and alopecia areata, expanding its use beyond orthopedic applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Platelet Rich Plasma for the Treatment of Scarring Alopecia Due to Discoid Lupus Erythematosus. Polster, H., Kagha, K., Luke, J.[2022]

Autologous platelet-rich plasma (PRP) therapy shows potential benefits in reproductive medicine, particularly in increasing endometrial thickness and improving pregnancy rates in women with thin endometrium.

In women with poor ovarian reserve, PRP therapy may enhance anti-Mullerian hormone (AMH) levels and reduce follicle-stimulating hormone (FSH) levels, suggesting a positive trend towards improved clinical outcomes, although more rigorous studies are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A narrative review of platelet-rich plasma (PRP) in reproductive medicine. Sharara, FI., Lelea, LL., Rahman, S., et al.[2022]

Platelet-rich plasma (PRP) shows promise as a treatment for pelvic floor disorders (PFDs), particularly for vaginal atrophy, where it improves symptoms and patient satisfaction, especially when hormone therapy is not an option.

PRP application has been associated with increased collagen concentration in pelvic organ prolapse (POP) and improvement in stress urinary incontinence symptoms, suggesting its potential effectiveness in managing various urogynaecological issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Emerging Role on the Use of Platelet-Rich Plasma Products in the Management of Urogynaecological Disorders. Prodromidou, A., Zacharakis, D., Athanasiou, S., et al.[2022]

Platelet-rich plasma (PRP) therapy may improve ovarian function and increase pregnancy chances in women with very low ovarian reserve and premature ovarian insufficiency, based on a review of 25 studies and 2 abstracts.

Despite some skepticism about PRP's role in fertility treatments, its low-risk profile and potential benefits warrant further investigation through larger randomized controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ovarian response to intraovarian platelet-rich plasma (PRP) administration: hypotheses and potential mechanisms of action. Seckin, S., Ramadan, H., Mouanness, M., et al.[2023]

In a study of 20 postmenopausal breast cancer survivors, the combination of autologous platelet-rich plasma and hyaluronic acid (A-PRP-HA) significantly improved symptoms of vulvovaginal atrophy (VVA), with VHI scores increasing from 10.7 to 20.75 after 6 months (P < 0.0001).

The treatment also led to a notable reduction in sexual distress, as indicated by a 17% decrease in the Female Sexual Distress (FSD) score, with no reported adverse events, suggesting A-PRP-HA is a safe alternative for those unable to use hormone therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of injecting platelet concentrate combined with hyaluronic acid for the treatment of vulvovaginal atrophy in postmenopausal women with history of breast cancer: a phase 2 pilot study. Hersant, B., SidAhmed-Mezi, M., Belkacemi, Y., et al.[2019]

Autologous plasma rich in platelets (PRP) has shown to improve gingival recession in chronic periodontitis, with a significant effect size (SMD of 0.54) based on data from four randomized controlled trials.

The efficacy of PRP in promoting complete healing of chronic skin ulcers remains inconclusive, and while adverse effects were reported, there were no significant differences between treatment groups, indicating a need for further research on its safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of the use of autologous plasma rich in platelets for tissue regeneration: a systematic review. Martínez-Zapata, MJ., Martí-Carvajal, A., Solà, I., et al.[2018]

In a study involving 10 mice, injections of platelet-rich plasma (PRP) significantly increased hair length compared to a control group, with notable differences observed at 13 and 18 days post-injection.

PRP also enhanced the formation of new blood vessels, as indicated by a higher number of CD31-positive vessels, suggesting that its mechanism of action may involve promoting angiogenesis to support hair growth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Platelet-rich plasma stimulates angiogenesis in mice which may promote hair growth. Cheng, H., Zhang, J., Li, J., et al.[2018]

Platelet-rich plasma (PRP) therapy, rich in growth factors, shows promising benefits in gynecology and obstetrics, particularly for conditions like thin endometrium and premature ovarian failure.

PRP is effective in enhancing wound healing and treating lower urinary tract symptoms, but further research is necessary to fully establish its efficacy across a broader range of medical conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Platelet Rich Plasma in Gynecology-Discovering Undiscovered-Review. Streit-Ciećkiewicz, D., Kołodyńska, A., Futyma-Gąbka, K., et al.[2022]

In a study involving 16 patients with recurrent vesicovaginal fistula (VVF), the use of platelet-rich plasma (PRP) injections before surgical repair showed promising results, with all patients remaining dry after the procedure.

This is the first study to evaluate PRP as a supportive treatment for recurrent VVF, suggesting that it may enhance surgical outcomes by promoting tissue healing and neovascularization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Platelet-Rich Plasma as Adjuvant Therapy for Recurrent Vesicovaginal Fistula: A Prospective Case Series. Streit-Ciećkiewicz, D., Futyma, K., Miotła, P., et al.[2020]

Citations

1. journals.lww.com journals.lww.com/greenjournal/fulltext/2025/11000/platelet_rich_plasma_for_genitourinary_syndrome_of.13.aspx

Platelet-Rich Plasma for Genitourinary Syndrome of... We conducted a prospective, single-arm pilot study of breast cancer survivors (stage 0–III) who reported vaginal dryness with or without dyspareunia.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40966714/

Platelet-Rich Plasma for Genitourinary Syndrome of ... Conclusion: A single treatment of autologous PRP injected diffusely through the vaginal canal and posterior fourchette is safe and feasible. In ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04535323

Platelet Rich Plasma for the Treatment of Genitourinary ... Giving platelet rich plasma may help relief symptoms of genitourinary syndrome of menopause in patients with breast cancer. Detailed Description. PRIMARY ...

4. journals.sagepub.com journals.sagepub.com/doi/full/10.1089/jwh.2023.0144

Comparable Efficacy of Submucosal Platelet-Rich Plasma ... We aimed to evaluate efficacy and tolerability of platelet-rich plasma (PRP) injections alone or in combination with noncrosslinked hyaluronic acid compared ...

5. jtgga.org jtgga.org/articles/evaluation-of-the-efficacy-of-injectable-platelet-rich-fibrin-in-genitourinary-syndrome-of-menopause/jtgga.galenos.2024.2024-5-6

Evaluation of the efficacy of injectable platelet-rich fibrin in ... Numerous studies have shown that PRP (14, 15, 27) are effective in treating GSM. However, we were unable to find any published study of the ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06028009

PRP Injections for Genitourinary Syndrome of Menopause Injection of PRP stimulates cell growth and can has been proven safe and effective for uses in orthopedics, dermatology, and gynecology. Despite the relative ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10906939/

Role of Platelet-Rich Plasma in Genitourinary Syndrome ... In cases of endometrial cancer, available data suggest that hormonal therapy may be considered safe in low-risk subtypes but should be avoided ...

8. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2025.1590078/full

Comparison of topical estrogen and platelet-rich plasma ... Conclusion: PRP injections are a safe and effective minimally invasive monotherapy for postmenopausal VVA and, consequently, vulvovaginal rejuvenation. PRP ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0378512225000040

Optimizing the regenerative potential of vaginal fibroblasts ... This study provides in vitro evidence supporting the potential of PRP and PRP-HA as autologous treatments for vaginal rejuvenation.