Platelet Rich Plasma for the Treatment of Genitourinary Syndrome of Menopause in Patients With Stage 0-III Breast Cancer

Study Overview
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Brief Summary
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This phase I trial is to find out possible benefits and/or side effects of platelet rich plasma for the treatment of genitourinary syndrome of menopause in patients with stage 0-III breast cancer. Platelet rich plasma is produced by collecting approximately 60-90 ml (4-6 tablespoons) of blood from the vein in patients' arm. The blood is spun using a centrifuge that separates the plasma and red blood cells. This allows doctors to collect the platelet rich plasma that is then loaded into individual, sterile syringes for injection. Giving platelet rich plasma may help relief symptoms of genitourinary syndrome of menopause in patients with breast cancer.

Detailed Description
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PRIMARY OBJECTIVE: I. To determine the safety and feasibility of use of platelet rich plasma (PRP) treatment in breast cancer survivors with genitourinary syndrome of menopause (GSM). SECONDARY OBJECTIVE: I. To determine the preliminary efficacy in treatment of vaginal atrophy, urinary symptoms, assessment of sexual function, quality of life symptoms, and patient global impression of improvement and tolerability. OUTLINE: Patients receive platelet rich plasma via injection into the vaginal area. After completion of study treatment, patients are followed up for 6 months.

Official Title
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A Phase I, Single Arm, Prospective Study to Evaluate the Treatment of Genitourinary Syndrome of Menopause With Platelet Rich Plasma (PRP) in Women With a History of Breast Cancer

Conditions
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Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Breast Adenocarcinoma, Genitourinary Syndrome of Menopause, Prognostic Stage 0 Breast Cancer AJCC v8, Prognostic Stage I Breast Cancer AJCC v8, Prognostic Stage IA Breast Cancer AJCC v8, Prognostic Stage IB Breast Cancer AJCC v8, Prognostic Stage II Breast Cancer AJCC v8, Prognostic Stage IIA Breast Cancer AJCC v8, Prognostic Stage IIB Breast Cancer AJCC v8, Prognostic Stage III Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8, Prognostic Stage IIIB Breast Cancer AJCC v8, Prognostic Stage IIIC Breast Cancer AJCC v8

Intervention / Treatment
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* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration
* Biological: Therapeutic Autologous Platelet-rich Plasma


Participation Criteria
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Eligibility Criteria
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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 with no evidence of recurrence. Additionally, 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 Triple negative or HER2 positive breast cancer =< 3 years from initial diagnosis Exclusion Criteria: 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 Hemoglobin < 11.6 g/dL or > 15.5 g/dL. 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 Hematocrit < 34.9% or > 44.9%. 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 White blood cell count < 3.4 X 10^9/L or > 10.5 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 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 human immunodeficiency virus (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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment of GSM (platelet rich plasma)<br>Patients receive platelet rich plasma via injection into the vaginal area. | Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>Biological: Therapeutic Autologous Platelet-rich Plasma<br>* Given via injection<br>* Other names: Therapeutic PRP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events | Safety endpoint is defined as a lack of serious adverse events. National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) will be used to grade the severity of adverse events that occur in this study. | Up to 2 weeks post-treatment | 
| Tolerability of planned injection regimen with pain scores | Feasibility will be based on whether or not 16 or more patients (> 80%) tolerate the planned injection regimen with pain scores during the procedure less than or equal to 4. | Up to 6 months post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in vaginal symptoms | Assessed using the vaginal assessment scale. Will be summarized using descriptive statistics. | Baseline up to 6 months | 
| Change in vulvar symptoms | Assessed using the vulvar assessment scale. Will be summarized using descriptive statistics. | Baseline up to 6 months | 
| Change in Day-to-Day Impact of Vaginal Aging score | Will be summarized using descriptive statistics. | Baseline up to 6 months | 
| Change in sexual function | Will assess change in Female Sexual Function Index score. Will be summarized using descriptive statistics. | Baseline up to 6 months | 
| Change in urinary symptoms | Assessed with Urogenital Distress Index 6 score. Will be summarized using descriptive statistics. | Baseline up to 6 months | 
| Objective vaginal changes | Assessed with vaginal maturation index | Baseline up to 6 months | 
| Objective vaginal changes | Assessed with vaginal health index score | Baseline up to 6 months | 
| Objective vaginal changes | Assessed with vaginal caliber. | Baseline up to 6 months |