Treatment of Genitourinary Syndrome with Platelet Rich Plasma

Overview

About this study

The purpose of this study is to determine the safety, feasibility, and efficacy of use of Platelet Rich Plasma (PRP) treatment in female breast cancer survivors with genitourinary syndrome of menopause (GSM).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 – III. Patients with stage III require three or more years from initial diagnosis with no evidence of recurrence.
  • Natural, surgical, or medically induced menopause.
  • 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 < 11.6 g/dL or > 15.5 g/dL;
    • hematocrit < 34.9% or > 44.9%;
    • white blood cell count < 3.4 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Anita Chen, M.D.

Open for enrollment

Contact information:

Reagan Dukes

(904) 953-5144

Dukes.Reagan@mayo.edu

More information

Publications

Publications are currently not available