Treatment of Genitourinary Syndrome of Menopause After Breast Cancer With PRP

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    20
  • sponsor
    Mayo Clinic
Updated on 27 January 2021

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)

Description

Genitourinary syndrome of menopause (GSM) is a term that encompasses a collection of symptoms and signs associated with a decrease in estrogen and other sex steroids involving changes to the labia majora/minora, clitoris, vestibule/introitus, vagina, urethra and bladder. The syndrome may include but is not limited to genital symptoms of dryness, burning, and irritation; sexual symptoms of lack of lubrication, discomfort or pain, and impaired function; and urinary symptoms of urgency, dysuria and recurrent urinary tract infections.The primary goal of treatment of GSM is symptom relief which may include non-hormonal and hormonal treatments. GSM is a challenging issue for breast cancer survivors on aromatase inhibitors due to symptomatic treatments that usually include estrogen which is contraindicated after treatment for breast cancer. GSM symptoms typically do not resolve without treatment and may worsen with time. PRP has been studied as a treatment option for various gynecological disorders and wound healing after cesarean sections and gynecological surgery.

Details
Condition Breast Cancer, Female Urogenital Diseases, Breast Cancer Diagnosis, Menopause Related Conditions, breast carcinoma, cancer, breast
Treatment PRP
Clinical Study IdentifierNCT04535323
SponsorMayo Clinic
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you female?
Do you have any of these conditions: Female Urogenital Diseases or Breast Cancer or Menopause Related Conditions or cancer, breast or Breast Cancer Diagnosis or breast carcinoma?
Do you have any of these conditions: breast carcinoma or cancer, breast or Breast Cancer or Breast Cancer Diagnosis or Menopause Related Conditions or Female Urogenital Diseases?
Do you have any of these conditions: Menopause Related Conditions or Breast Cancer Diagnosis or Female Urogenital Diseases or Breast Cancer or cancer, breast or breast carcinoma?
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, three or more years 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
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
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