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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine whether platelet rich plasma (PRP) injections to the vulva and vagina will improve symptoms of genitourinary syndrome of menopause (GSM) in breast cancer patients.

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.

What data supports the effectiveness of PRP therapy for genitourinary syndrome in breast cancer survivors?

Research suggests that platelet-rich plasma (PRP) therapy may be a promising alternative for treating vaginal atrophy and other urogynaecological disorders, especially when hormone therapy is not an option. Studies have shown favorable outcomes in improving symptoms and patient satisfaction, indicating its potential effectiveness. ^{1 2 3 4 5}

Is PRP therapy generally safe for humans?

PRP therapy, which uses a concentration of a person's own platelets, has been used safely in various treatments, including wound healing and hair growth, with no major safety concerns reported in the studies. ^{3 6 7 8 9}

How is PRP therapy different from other treatments for genitourinary syndrome in breast cancer survivors?

PRP therapy is unique because it uses the patient's own blood components, specifically platelets, to promote tissue regeneration and healing, making it a promising option for those who cannot use hormone therapy. It is considered a cost-effective and easy-to-apply alternative, with potential benefits in improving symptoms of vaginal atrophy and urinary incontinence. ^{1 2 5 10 11}

Research Team

Kristin E Rojas, MD

Principal Investigator

University of Miami

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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) 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]

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]

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]

References

1. United States 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. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

The Emerging Role on the Use of Platelet-Rich Plasma Products in the Management of Urogynaecological Disorders. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Autologous platelet-rich plasma for treating chronic wounds. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Platelet-Rich Plasma as Adjuvant Therapy for Recurrent Vesicovaginal Fistula: A Prospective Case Series. [2020]

5. Netherlands pubmed.ncbi.nlm.nih.gov

A narrative review of platelet-rich plasma (PRP) in reproductive medicine. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of the use of autologous plasma rich in platelets for tissue regeneration: a systematic review. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Autologous platelet-rich plasma for treating chronic wounds. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Platelet-rich plasma stimulates angiogenesis in mice which may promote hair growth. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Platelet Rich Plasma for the Treatment of Scarring Alopecia Due to Discoid Lupus Erythematosus. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Ovarian response to intraovarian platelet-rich plasma (PRP) administration: hypotheses and potential mechanisms of action. [2023]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Platelet Rich Plasma in Gynecology-Discovering Undiscovered-Review. [2022]