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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
20
Ancillary studies
Ancillary studies
Given via injection
Mayo Clinic in Florida
Jacksonville, Florida, United States
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.
Time frame: 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.
Time frame: Up to 6 months post-treatment
Change in vaginal symptoms
Assessed using the vaginal assessment scale. Will be summarized using descriptive statistics.
Time frame: Baseline up to 6 months
Change in vulvar symptoms
Assessed using the vulvar assessment scale. Will be summarized using descriptive statistics.
Time frame: Baseline up to 6 months
Change in Day-to-Day Impact of Vaginal Aging score
Will be summarized using descriptive statistics.
Time frame: Baseline up to 6 months
Change in sexual function
Will assess change in Female Sexual Function Index score. Will be summarized using descriptive statistics.
Time frame: Baseline up to 6 months
Change in urinary symptoms
Assessed with Urogenital Distress Index 6 score. Will be summarized using descriptive statistics.
Time frame: Baseline up to 6 months
Objective vaginal changes - vaginal maturation index
Assessed with vaginal maturation index
Time frame: Baseline up to 6 months
Objective vaginal changes - vaginal health index score
Assessed with vaginal health index score
Time frame: Baseline up to 6 months
Objective vaginal changes - vaginal caliber
Assessed with vaginal caliber
Time frame: Baseline up to 6 months
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