- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04535323
Platelet Rich Plasma for the Treatment of Genitourinary Syndrome of Menopause in Patients With Stage 0-III Breast Cancer
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
Study Overview
Status
Conditions
- 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
- 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
- Anatomic Stage 0 Breast Cancer AJCC v8
- Prognostic Stage 0 Breast Cancer AJCC v8
- Genitourinary Syndrome of Menopause
- Breast Adenocarcinoma
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 Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Florida
-
Jacksonville, Florida, United States, 32224-9980
- Mayo Clinic in Florida
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment of GSM (platelet rich plasma)
Patients receive platelet rich plasma via injection into the vaginal area.
|
Ancillary studies
Other Names:
Ancillary studies
Given via injection
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 2 weeks post-treatment
|
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.
|
Up to 6 months post-treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in vaginal symptoms
Time Frame: Baseline up to 6 months
|
Assessed using the vaginal assessment scale.
Will be summarized using descriptive statistics.
|
Baseline up to 6 months
|
Change in vulvar symptoms
Time Frame: Baseline up to 6 months
|
Assessed using the vulvar assessment scale.
Will be summarized using descriptive statistics.
|
Baseline up to 6 months
|
Change in Day-to-Day Impact of Vaginal Aging score
Time Frame: Baseline up to 6 months
|
Will be summarized using descriptive statistics.
|
Baseline up to 6 months
|
Change in sexual function
Time Frame: Baseline up to 6 months
|
Will assess change in Female Sexual Function Index score.
Will be summarized using descriptive statistics.
|
Baseline up to 6 months
|
Change in urinary symptoms
Time Frame: Baseline up to 6 months
|
Assessed with Urogenital Distress Index 6 score.
Will be summarized using descriptive statistics.
|
Baseline up to 6 months
|
Objective vaginal changes - vaginal maturation index
Time Frame: Baseline up to 6 months
|
Assessed with vaginal maturation index
|
Baseline up to 6 months
|
Objective vaginal changes - vaginal health index score
Time Frame: Baseline up to 6 months
|
Assessed with vaginal health index score
|
Baseline up to 6 months
|
Objective vaginal changes - vaginal caliber
Time Frame: Baseline up to 6 months
|
Assessed with vaginal caliber
|
Baseline up to 6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Anita H. Chen, M.D., Mayo Clinic
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-002712 (Mayo Clinic in Florida)
- NCI-2021-02777 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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