Platelet Rich Plasma for the Treatment of Genitourinary Syndrome of Menopause in Patients With Stage 0-III Breast Cancer
Primary Purpose
Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Quality-of-Life Assessment
Questionnaire Administration
Therapeutic Autologous Platelet-rich Plasma
Sponsored by
About this trial
This is an interventional supportive care trial for Anatomic Stage 0 Breast Cancer AJCC v8
Eligibility Criteria
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. 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
Sites / Locations
- Mayo Clinic in FloridaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment of GSM (platelet rich plasma)
Arm Description
Patients receive platelet rich plasma via injection into the vaginal area.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Change in vaginal symptoms
Assessed using the vaginal assessment scale. Will be summarized using descriptive statistics.
Change in vulvar symptoms
Assessed using the vulvar assessment scale. Will be summarized using descriptive statistics.
Change in Day-to-Day Impact of Vaginal Aging score
Will be summarized using descriptive statistics.
Change in sexual function
Will assess change in Female Sexual Function Index score. Will be summarized using descriptive statistics.
Change in urinary symptoms
Assessed with Urogenital Distress Index 6 score. Will be summarized using descriptive statistics.
Objective vaginal changes
Assessed with vaginal maturation index
Objective vaginal changes
Assessed with vaginal health index score
Objective vaginal changes
Assessed with vaginal caliber.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04535323
Brief Title
Platelet Rich Plasma for the Treatment of Genitourinary Syndrome of Menopause in Patients With Stage 0-III Breast Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 23, 2020 (Actual)
Primary Completion Date
October 15, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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:
Patients receive platelet rich plasma via injection into the vaginal area.
After completion of study treatment, patients are followed up for 6 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment of GSM (platelet rich plasma)
Arm Type
Experimental
Arm Description
Patients receive platelet rich plasma via injection into the vaginal area.
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Biological
Intervention Name(s)
Therapeutic Autologous Platelet-rich Plasma
Other Intervention Name(s)
PRP, Therapeutic PRP
Intervention Description
Given via injection
Primary Outcome Measure Information:
Title
Incidence of adverse events
Description
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
Title
Tolerability of planned injection regimen with pain scores
Description
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
Secondary Outcome Measure Information:
Title
Change in vaginal symptoms
Description
Assessed using the vaginal assessment scale. Will be summarized using descriptive statistics.
Time Frame
Baseline up to 6 months
Title
Change in vulvar symptoms
Description
Assessed using the vulvar assessment scale. Will be summarized using descriptive statistics.
Time Frame
Baseline up to 6 months
Title
Change in Day-to-Day Impact of Vaginal Aging score
Description
Will be summarized using descriptive statistics.
Time Frame
Baseline up to 6 months
Title
Change in sexual function
Description
Will assess change in Female Sexual Function Index score. Will be summarized using descriptive statistics.
Time Frame
Baseline up to 6 months
Title
Change in urinary symptoms
Description
Assessed with Urogenital Distress Index 6 score. Will be summarized using descriptive statistics.
Time Frame
Baseline up to 6 months
Title
Objective vaginal changes
Description
Assessed with vaginal maturation index
Time Frame
Baseline up to 6 months
Title
Objective vaginal changes
Description
Assessed with vaginal health index score
Time Frame
Baseline up to 6 months
Title
Objective vaginal changes
Description
Assessed with vaginal caliber.
Time Frame
Baseline up to 6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anita H Chen
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224-9980
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Referral Office
Phone
855-776-0015
Email
mayocliniccancerstudies@mayo.edu
First Name & Middle Initial & Last Name & Degree
Anita H. Chen, M.D.
12. IPD Sharing Statement
Learn more about this trial
Platelet Rich Plasma for the Treatment of Genitourinary Syndrome of Menopause in Patients With Stage 0-III Breast Cancer
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