Platelet Rich Plasma for Genitourinary Syndrome in Breast Cancer Patients

Overseen By Chary Aleger

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: Mayo Clinic

Must not be taking: Hormone therapy, SERMs

Disqualifiers: Vulvovaginal conditions, Pelvic pain, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

20 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

Research Team

Anita H. Chen, M.D.

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Treatment of GSM (platelet rich plasma) Experimental Treatment 3 Interventions

Patients receive platelet rich plasma via injection into the vaginal area.

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+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laser treatment for the management of genitourinary syndrome of menopause after breast cancer. Hope or hype? Tranoulis, A., Georgiou, D., Michala, L.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Laser treatment for the management of genitourinary syndrome of menopause after breast cancer. Hope or hype? [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Management of genitourinary symptoms in patients with breast cancer: an updated systematic review of available evidence from randomized trials. [2023]

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

Female genitourinary treatments in aesthetics. [2022]

4. Japan pubmed.ncbi.nlm.nih.gov

Genitourinary symptoms in women with breast cancer: what do oncology health professionals think and do about them? [2022]

5. France pubmed.ncbi.nlm.nih.gov

[Management of vulvovaginal atrophy: Physical therapies. Postmenopausal women management: CNGOF and GEMVi clinical practice guidelines]. [2023]

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

Assessment of urinary gonadotropin in solid carcinomas other than gynecological tumors. [2015]

7. Greece pubmed.ncbi.nlm.nih.gov

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]

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

Serum TPS versus TPA in Egyptian bladder cancer patients. [2022]

9. Croatia pubmed.ncbi.nlm.nih.gov

Cancer-associated serum globulin determined in patients with cervical, endometrial and ovarian cancer. [2005]

10. Australia pubmed.ncbi.nlm.nih.gov

Extramammary Paget's disease of the glans penis secondary to urethral recurrence of bladder carcinoma after radical cystectomy: A case report. [2022]