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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Incidence of adverse events
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Incidence of adverse events
Time Frame: 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
Time Frame: 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 Outcomes
- Change in vaginal 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)
- Objective vaginal changes - vaginal caliber(Baseline up to 6 months)
- Change in vulvar symptoms(Baseline up to 6 months)
- Objective vaginal changes - vaginal health index score(Baseline up to 6 months)
- Change in urinary symptoms(Baseline up to 6 months)
- Objective vaginal changes - vaginal maturation index(Baseline up to 6 months)