20 Participants Needed

Platelet Rich Plasma for Genitourinary Syndrome in Breast Cancer Patients

LC
ES
CA
Overseen ByChary Aleger
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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.

How does the treatment Therapeutic Autologous Platelet-rich Plasma differ from other treatments for genitourinary syndrome in breast cancer patients?

Therapeutic Autologous Platelet-rich Plasma is unique because it uses a patient's own blood components to promote healing and tissue regeneration, which is different from traditional treatments that may rely on hormone replacement or other medications. This approach is particularly novel for genitourinary syndrome in breast cancer patients, as it avoids the use of hormones, which can be contraindicated in these individuals.12345

What data supports the effectiveness of the treatment Therapeutic Autologous Platelet-rich Plasma for genitourinary syndrome in breast cancer patients?

Research suggests that platelet-rich plasma (PRP) is being explored as an alternative treatment for genitourinary syndrome of menopause, especially when other treatments are not suitable or effective. PRP has been proposed alongside other therapies like lasers and hyaluronic acid injections to improve symptoms such as vaginal dryness and urinary incontinence.678910

Who Is on the Research Team?

AH

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

My breast cancer is triple negative or HER2 positive and was diagnosed within the last 3 years.
My breast cancer is confirmed and has not come back.
I have gone through menopause naturally, surgically, or due to medical treatment.
See 6 more

Exclusion Criteria

My pelvic organ prolapse is more severe than stage II.
I do not have any serious illnesses or social situations that would stop me from following the study's requirements.
My white blood cell count is either too low or too high.
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive platelet rich plasma via injection into the vaginal area

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Therapeutic Autologous Platelet-rich Plasma
Trial Overview 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.
How Is the Trial Designed?
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

Laser treatments, specifically fractional CO2 and vaginal erbium lasers, may significantly alleviate symptoms of genitourinary syndrome of menopause (GSM) in breast cancer survivors, with improvements in sexual function and vaginal health lasting up to 12 months based on six observational studies.
The safety profile of these laser treatments is promising, as no adverse effects were reported, and only a few patients discontinued treatment due to discomfort, indicating a good tolerability among participants.
Laser treatment for the management of genitourinary syndrome of menopause after breast cancer. Hope or hype?Tranoulis, A., Georgiou, D., Michala, L.[2021]

Citations

Laser treatment for the management of genitourinary syndrome of menopause after breast cancer. Hope or hype? [2021]
Management of genitourinary symptoms in patients with breast cancer: an updated systematic review of available evidence from randomized trials. [2023]
Female genitourinary treatments in aesthetics. [2022]
Genitourinary symptoms in women with breast cancer: what do oncology health professionals think and do about them? [2022]
[Management of vulvovaginal atrophy: Physical therapies. Postmenopausal women management: CNGOF and GEMVi clinical practice guidelines]. [2023]
Assessment of urinary gonadotropin in solid carcinomas other than gynecological tumors. [2015]
UGP--a tumor marker of gynecologic and breast malignancies? Specificity and sensitivity in pretherapeutic patients and the influence of hormonal substitution on the expression of UGP. [2015]
Serum TPS versus TPA in Egyptian bladder cancer patients. [2022]
Cancer-associated serum globulin determined in patients with cervical, endometrial and ovarian cancer. [2005]
Extramammary Paget's disease of the glans penis secondary to urethral recurrence of bladder carcinoma after radical cystectomy: A case report. [2022]
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