Platelet Rich Plasma for the Treatment of Genitourinary Syndrome of Menopause in Patients With Stage 0-III Breast Cancer
NCT04535323 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2024-04-03
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.
Conditions
- 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
Interventions
- OTHER
-
Quality-of-Life Assessment
Ancillary studies
- OTHER
-
Questionnaire Administration
Ancillary studies
- BIOLOGICAL
-
Therapeutic Autologous Platelet-rich Plasma
Given via injection
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Anita H. Chen, M.D. · Mayo Clinic
Study Design
- Allocation
- NA
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-09-23
- Primary Completion
- 2024-01-10
- Completion
- 2024-01-10
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Estradiol-Receptor Blockade in Older Men and Women
NCT02271282 ·Status: COMPLETED ·Phase: PHASE1
-
Effects of Hormone Replacement Therapy on Cardiovascular Risk and Body Composition Parameters
NCT04453332 ·Status: UNKNOWN ·Phase: NA
-
A Study of 2 Different Formulations of Blosozumab (LY2541546) in Post Menopausal Women
NCT02337387 ·Status: TERMINATED ·Phase: PHASE1
-
PhytoSERM for Menopausal Hot Flashes and Sustained Brain Health
NCT06186531 ·Status: RECRUITING ·Phase: PHASE2
-
A Randomized, Double Blind, Placebo Controlled, Clinical Study to Examine the Benefits of an Oral Product in Panelists With Menopausal Symptoms Including Vasomotor Symptoms (VMS).
NCT07033013 ·Status: RECRUITING ·Phase: NA
-
A Study to Assess the Safety and Tolerability of Fezolinetant in Women Seeking Treatment for Relief of Vasomotor Symptoms (VMS) Associated With Menopause
NCT04451226 ·Status: COMPLETED ·Phase: PHASE3
-
Hormone Replacement Therapy for Hot Flashes and/or Vaginal Symptoms in Postmenopausal Women Receiving Tamoxifen for Breast Cancer
NCT00026286 ·Status: COMPLETED ·Phase: PHASE3
-
Effects of Ospemifene on Pelvic Vascularity and Blood Flow
NCT02010580 ·Status: WITHDRAWN
-
Vasomotor Symptoms (VMS) Progesterone Study: Vasomotor Symptoms and Endothelial Function - Trial of Oral Micronized Progesterone
NCT00152438 ·Status: UNKNOWN ·Phase: PHASE2
-
MT-8554 for Reduction of Vasomotor Symptoms in Postmenopausal Women
NCT03291067 ·Status: COMPLETED ·Phase: PHASE2
-
Effect of a GnRH Analog on Hepatic Steatosis
NCT06523530 ·Status: RECRUITING ·Phase: PHASE4
-
A Study of Fezolinetant to Treat Hot Flashes in Women Going Through Menopause
NCT05033886 ·Status: COMPLETED ·Phase: PHASE3
-
Impact of Treatment Induced Premature Menopause on Quality of Life
NCT00185718 ·Status: COMPLETED
-
Efficacy of Non-ablative Radiofrequency Combined With Pelvic Floor Muscle Training for Genitourinary Syndrome of Menopause in Breast Cancer Survivors (RF-SGM)
NCT07034976 ·Status: RECRUITING ·Phase: NA
-
Effects of Ovarian Hormone Suppression on Vascular and Cognitive Function
NCT03112226 ·Status: COMPLETED ·Phase: NA
-
A Safety and Efficacy Study of the Combination Estradiol and Progesterone to Treat Vasomotor Symptoms
NCT01942668 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy of Nano-Pso Therapy in Menopause
NCT06432816 ·Status: RECRUITING ·Phase: NA
-
A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Chinese Women Going Through Menopause
NCT06812754 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause
NCT05042362 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women in Asia Going Through Menopause
NCT04234204 ·Status: COMPLETED ·Phase: PHASE3
-
Long-term Safety and Efficacy Study of MT-8554 in Postmenopausal Women With Vasomotor Symptoms
NCT03541200 ·Status: COMPLETED ·Phase: PHASE2
-
A Randomized Controlled Trial of Menopausal Tool/App for Women
NCT06919887 ·Status: ENROLLING_BY_INVITATION ·Phase: NA
-
Partial Double-Blind, Placebo-Controlled Study to Assess the Effect of Anastrozole on the Endometrium in Healthy Volunteers
NCT00467493 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Assess Long-term Safety of Fezolinetant Given to Japanese Women Going Through Menopause
NCT06206421 ·Status: COMPLETED ·Phase: PHASE3
-
GSM (Genitourinary Syndrome Of Menopause) Management In Breast Cancer Survivors
NCT03185169 ·Status: TERMINATED ·Phase: EARLY_PHASE1