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

Phase 1

Completed

• Conditions: Anatomic Stage 0 Breast Cancer AJCC v8; Anatomic Stage I Breast Cancer AJCC v8; Prognostic Stage IB Breast Cancer AJCC v8; Prognostic Stage II Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage IIA Breast Cancer AJCC v8; Anatomic Stage IIIC Breast Cancer AJCC v8; Prognostic Stage III Breast Cancer AJCC v8; Anatomic Stage IB Breast Cancer AJCC v8; Anatomic Stage IIB Breast Cancer AJCC v8
• Interventions: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Biological: Therapeutic Autologous Platelet-rich Plasma

• Registration Number: NCT04535323
• Lead Sponsor: Mayo Clinic

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-08-26
• Study First Submitted QC: 2020-08-31
• Study First Posted: 2020-09-01
• Study Start: 2020-09-23
• Primary Completion: 2024-01-10
• Study Completion: 2024-01-10
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment of GSM (platelet rich plasma)	Quality-of-Life Assessment	Patients receive platelet rich plasma via injection into the vaginal area.
Treatment of GSM (platelet rich plasma)	Questionnaire Administration	Patients receive platelet rich plasma via injection into the vaginal area.
Treatment of GSM (platelet rich plasma)	Therapeutic Autologous Platelet-rich Plasma	Patients receive platelet rich plasma via injection into the vaginal area.

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events	Up to 2 weeks post-treatment	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.
Tolerability of planned injection regimen with pain scores	Up to 6 months post-treatment	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States