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

Anatomic Stage III Breast Cancer AJCC v8 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04535323
• Other study ID #: 20-002712
• Secondary ID: NCI-2021-02777
• Status: Completed
• Phase: Phase 1
• Start date: September 23, 2020
• Est. completion date: January 10, 2024

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 10, 2024
• Est. primary completion date: January 10, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• 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
• Breast Carcinoma In Situ
• Breast Neoplasms
• 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
• Syndrome

Intervention

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Biological:
• Therapeutic Autologous Platelet-rich Plasma
Given via injection

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

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