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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-02777 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment of GSM (platelet rich plasma) | Experimental | Patients receive platelet rich plasma via injection into the vaginal area. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quality-of-Life Assessment | Other | Ancillary studies |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in vaginal symptoms | Assessed using the vaginal assessment scale. Will be summarized using descriptive statistics. | Baseline up to 6 months |
| Change in vulvar symptoms | Assessed using the vulvar assessment scale. Will be summarized using descriptive statistics. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anita H. Chen, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Jacksonville | Florida | 32224-9980 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40966714 | Derived | Chen AH, Trabuco EC, Chumsri S, Thielen JM, Cornella JL, Shapiro SA, Heckman MG, Dukes RE, Arthurs JR, Blumenfeld SG, Yi J. Platelet-Rich Plasma for Genitourinary Syndrome of Menopause in Breast Cancer Survivors. Obstet Gynecol. 2025 Nov 1;146(5):728-736. doi: 10.1097/AOG.0000000000006081. Epub 2025 Sep 19. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Questionnaire Administration | Other | Ancillary studies |
|
| Therapeutic Autologous Platelet-rich Plasma | Biological | Given via injection |
|
|
| Baseline up to 6 months |
| Change in Day-to-Day Impact of Vaginal Aging score | Will be summarized using descriptive statistics. | Baseline up to 6 months |
| Change in sexual function | Will assess change in Female Sexual Function Index score. Will be summarized using descriptive statistics. | Baseline up to 6 months |
| Change in urinary symptoms | Assessed with Urogenital Distress Index 6 score. Will be summarized using descriptive statistics. | Baseline up to 6 months |
| Objective vaginal changes - vaginal maturation index | Assessed with vaginal maturation index | Baseline up to 6 months |
| Objective vaginal changes - vaginal health index score | Assessed with vaginal health index score | Baseline up to 6 months |
| Objective vaginal changes - vaginal caliber | Assessed with vaginal caliber | Baseline up to 6 months |
| ID | Term |
|---|---|
| D000071960 | Breast Carcinoma In Situ |
| ID | Term |
|---|---|
| D002278 | Carcinoma in Situ |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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