Treatment of Genitourinary Syndrome of Menopause After Breast Cancer With PRP

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

The goal of this study is to determine the safety, feasibility and preliminary efficacy of use of platelet rich plasma (PRP) treatment in female breast cancer survivors with genitourinary syndrome of menopause (GSM)

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic

Criteria

Inclusion Criteria:

• Ability to provide written informed consent or have an appropriate representative available to do so

• Ability to complete questionnaires by themselves or with assistance

• Ability to comply with treatment plan and follow-up visits

• Female patients ≥ 18 years

• Histological confirmation of adenocarcinoma of the breast stage 0 - Patients with stage III require three or more year from initial diagnosis with no evidence of recurrence.

• Natural, surgical, or medically induced menopause of less than 10 years duration

• Self-report of vaginal itching, irritation, burning, dryness, or dyspareunia

Exclusion Criteria:

• Triple negative or HER2 positive breast cancer < 3 years from initial diagnosis

• Receiving any form of hormone replacement therapy, including topical estrogens, testosterone, and dehydroepiandrosterone (DHEA) or selective estrogen receptor modulator (SERM), including tamoxifen and ospemifene in the previous 3 months prior to enrollment

• Personal history of vulvovaginal conditions such as lichen sclerosis, lichen planus, vulvovaginal condyloma, vaginal intraepithelial neoplasia, vaginal carcinoma, history of cervical or other gynecologic cancer, radical pelvic surgery, acute or recurrent urinary tract infection, genital infection, history of vaginal or pelvic radiation

• Chronic pelvic pain, current pelvic tension myalgia/muscle hypertonicity

• Pelvic organ prolapse greater than stage II

• Pelvic surgery within 6 months

• Known allergy to lidocaine or prilocaine

• Known allergy to silicone

• Use of vaginal moisturizers, lubricants, or homeopathic preparations within 2 weeks of therapy

• Abnormal lab values to include: hemoglobin < 12.0 g/dL or > 15.5 g/dL; hematocrit < 34.9% or > 44.5%; white blood cell count < 3.5 X 10(9)/L or > 10.5 X 10(9)/L; platelet count < 150 X 10(9)/L or > 450 X 10(9)/L. If the laboratory reports a single, non-clinically significant result for any of these studies and is the only excluding factor it may be repeated 1 week later if the patient wishes. Normalization of that laboratory study will then be considered non-exclusionary.

• Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of the treatment

• Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy. NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements