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

NCT04535323 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: 20-002712NCI-2021-02777
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Change in vaginal symptoms

  Baseline up to 6 months

• Change in vulvar symptoms

  Baseline up to 6 months

• Change in Day-to-Day Impact of Vaginal Aging score

  Baseline up to 6 months

• Change in sexual function

  Baseline up to 6 months

• Change in urinary symptoms

  Baseline up to 6 months

Study Arms (1)

Treatment of GSM (platelet rich plasma)

EXPERIMENTAL

Patients receive platelet rich plasma via injection into the vaginal area.

Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Biological: Therapeutic Autologous Platelet-rich Plasma

Interventions

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment of GSM (platelet rich plasma)

Questionnaire Administration OTHER

Ancillary studies

Treatment of GSM (platelet rich plasma)

Therapeutic Autologous Platelet-rich Plasma BIOLOGICAL

Given via injection

Also known as: PRP, Therapeutic PRP

Treatment of GSM (platelet rich plasma)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Related Publications (1)

• Chen AH, Trabuco EC, Chumsri S, Thielen JM, Cornella JL, Shapiro SA, Heckman MG, Dukes RE, Arthurs JR, Blumenfeld SG, Yi J. Platelet-Rich Plasma for Genitourinary Syndrome of Menopause in Breast Cancer Survivors. Obstet Gynecol. 2025 Nov 1;146(5):728-736. doi: 10.1097/AOG.0000000000006081. Epub 2025 Sep 19.

  PMID: 40966714 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Breast Carcinoma In Situ

Condition Hierarchy (Ancestors)

Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Breast Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Anita H. Chen, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: September 1, 2020
• Study Start: September 23, 2020
• Primary Completion: January 10, 2024
• Study Completion: January 10, 2024
• Last Updated: April 3, 2024

Record last verified: 2024-04

Locations

US (1)