Platelet-rich Plasma for Improving Symptoms of Genitourinary Syndrome of Menopause in Breast Cancer Patients

Status: closed to accrual

This phase II trial evaluates whether platelet-rich plasma injections to the vulva and vagina improve symptoms of genitourinary syndrome of menopause (GSM) in breast cancer patients. GSM includes a variety of symptoms such as vaginal dryness or vaginal atrophy (the lining of the vagina gets drier and thinner), painful sex, and pelvic floor muscle dysfunction (difficulty controlling your pelvic floor muscles that may result in problems with urination, bowel movements, or having sex), among others. Women with GSM often have difficulty with pelvic exams or sexual intercourse due to pain. Platelet-rich plasma consists of two elements: plasma, or the liquid portion of blood, and platelets, a type of blood cell that plays an important role in healing throughout the body. Platelets are well-known for their clotting abilities, but they also contain growth factors that can trigger cell reproduction and stimulate tissue regeneration or healing in the treated area. Platelet-rich plasma is simply blood that contains more platelets than normal. Platelet-rich plasma may be a safe and effective non-hormonal treatment for breast cancer patients experiencing symptoms of GSM.

Inclusion Criteria

Female patients who are age 18 years and older
Patients must have a history of biopsy-proven ductal carcinoma in situ (DCIS) or stage I-III breast cancer and must be currently undergoing treatment or have completed primary treatment
Patients must be found to have a vaginal health index (VHI) score of < 15
Patients may be currently using endocrine therapy (ovarian function suppression, tamoxifen, or aromatase inhibitors). Patients not currently using endocrine therapy will also be eligible for participation since patients more than 5 or 10 years from diagnosis (and therefore having completed adjuvant endocrine therapy) may be enrolled
Some patients with triple negative breast cancer who receive chemotherapy also experience GSM related to ovarian function decline outside of the setting of ovarian suppression, and therefore patients with either estrogen receptor positive (ER+) or estrogen receptor negative (ER-) breast cancer will be allowed to participate
Patients must provide written informed consent for participation in this study
Patients are allowed to have used non-hormonal moisturizers but if they have previously used hormonal moisturizers, they will be asked to stop the use for one month prior to the first planned treatment, termed the “washout period”, if needed

Exclusion Criteria

Patients with any systemic or topical hormone replacement therapy within 3 months prior to enrollment, known genital infection, coagulation disorders, or on anticoagulant therapy or turmeric-containing supplements within the prior 2 weeks will be excluded
Women who are pregnant or who plan to become pregnant within the following six months will be excluded since the impact of recent PRP injections to the vulva and the impact on obstetric injury during vaginal delivery has not been studied

PRIMARY OBJECTIVE:

I. Determine whether two sessions of autologous platelet rich plasma (PRP) injections to the vulva/vagina lead to statistically significant improvement in patient-reported symptoms of GSM.

SECONDARY OBJECTIVES:

I. Determine whether two sessions of autologous PRP injections lead to:

Ia. Improvement in vulvovaginal exam of patients with GSM;

Ib. Improvement in patient-reported overall sexual function;

Ic. Decrease in patient-reported sexual-related distress.

EXPLORATORY OBJECTIVES:

I. Increase or return of patient-reported sexual activity.

II. Improvement in patient-reported endocrine therapy compliance.

OUTLINE:

Patients undergo collection of blood samples for the creation of platelet-rich plasma. Patients then receive platelet-rich plasma injections to the vulva and vagina twice, approximately one month apart, on study. Patients also undergo pelvic exams throughout the study.

After completion of study intervention, patients are followed up at months 2 and 7.

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Platelet-rich Plasma for Improving Symptoms of Genitourinary Syndrome of Menopause in Breast Cancer Patients

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