Platelet Rich Plasma for Genitourinary Syndrome in Breast Cancer Patients
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether platelet-rich plasma (PRP) can relieve symptoms of genitourinary syndrome of menopause in women treated for breast cancer. PRP is made from a small blood sample, processed to concentrate the platelets, and then injected into the vaginal area. Women who have undergone menopause and have breast cancer stage 0-III, experiencing symptoms like vaginal dryness or discomfort, might be suitable for this study. The goal is to determine if PRP can ease these symptoms without major side effects. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this innovative therapy.
Do I have to stop taking my current medications for the trial?
The trial requires that you stop taking hormone replacement therapies, including topical estrogens, testosterone, and certain medications like tamoxifen, at least 3 months before joining. You also need to avoid using vaginal moisturizers or lubricants within 2 weeks of starting the therapy.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that platelet-rich plasma (PRP) is generally safe for treating menopause symptoms affecting the urinary and genital areas. Studies have found that a single PRP injection into the vaginal area is both safe and practical. PRP is made from a small sample of the patient's own blood, processed to concentrate the platelets before injection. This method has proven safe in other areas, such as bone and skin treatments.
For breast cancer survivors, PRP is considered a safe, non-hormonal treatment option. It can help relieve symptoms like dryness and itching without major side effects. Overall, existing research supports the safety of PRP for this purpose, making it a promising option for those experiencing these symptoms after breast cancer.12345Why do researchers think this study treatment might be promising?
Unlike traditional treatments for genitourinary syndrome of menopause (GSM), which often include hormonal therapies and lubricants, the platelet-rich plasma (PRP) treatment is derived from the patient’s own blood. Researchers are excited about this approach because PRP involves injecting concentrated platelets directly into the vaginal area, which may promote tissue regeneration and healing. This method offers a non-hormonal alternative, making it particularly appealing for breast cancer patients who may need to avoid hormone-based treatments. Additionally, PRP could potentially provide longer-lasting relief and improve tissue function without the side effects associated with other therapies.
What evidence suggests that platelet rich plasma might be an effective treatment for genitourinary syndrome?
Studies have shown that platelet-rich plasma (PRP) injections might be a promising treatment for genitourinary syndrome of menopause (GSM) in breast cancer survivors. Early research indicates that PRP is safe and effective in reducing symptoms like dryness and discomfort. Specifically, one study found that injecting PRP into the vaginal area improved these symptoms. In this trial, participants will receive PRP injections as a non-hormonal option, crucial for breast cancer survivors who must avoid hormone therapies. Overall, initial findings suggest that PRP could be a valuable treatment option for managing GSM symptoms.12567
Who Is on the Research Team?
Anita H. Chen, M.D.
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive platelet rich plasma via injection into the vaginal area
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Therapeutic Autologous Platelet-rich Plasma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
National Cancer Institute (NCI)
Collaborator