Fisetin to Improve Physical Function in Stage I-III Breast Cancer Survivors
Part of paid clinical trials in Alhambra, California.
- Sponsor
- Jonsson Comprehensive Cancer Center
- Study ID
- NCT05595499
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Anatomic Stage I Breast Cancer AJCC v8
- Anatomic Stage II Breast Cancer AJCC v8
- Anatomic Stage III Breast Cancer AJCC v8
Eligibility Criteria
- Sex
- FEMALE
- Age
- N/A - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Biospecimen Collection — PROCEDUREUndergo collection of blood samples
- Fisetin — DRUGGiven PO
- Placebo Administration — DRUGGiven PO
- Quality-of-Life Assessment — OTHERAncillary studies
- Questionnaire Administration — OTHERAncillary studies
Study Details
This phase II trial tests whether fisetin works to improve physical function in women who have received chemotherapy for stage I-III breast cancer treatment. Fisetin is a naturally occurring substance that is found in strawberries and other foods. Fisetin eliminates cells that have undergone a process called senescence. Senescence is when a cell ages and permanently stops dividing but does not die. Over time, large numbers of these cells build up in tissues throughout the body and can release harmful substances that causes inflammation and damages nearby healthy cells. Studies have shown that chemotherapy causes a build-up of these senescent cells. Giving fisetin may eliminate senescent cells and improve physical function in postmenopausal women who have received chemotherapy for breast cancer.
Key Dates
- Start date
- Mar 27, 2023
- Status verified
- May 2025
- Primary completion
- Jun 1, 2026
- Completion
- Jun 1, 2026
Study Design
- Enrollment
- 88 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Arm A (fisetin)Patients receive fisetin PO on days 1, 2, and 3. Treatment repeats every 2 weeks for up to 8 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples throughout the trial.
- Placebo Comparator: Arm B (placebo)Patients receive placebo PO on the trial. on days 1, 2, and 3. Treatment repeats every 2 weeks for up to 8 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples throughout the trial.
Primary Outcome Measure
Change in 6-minute walk distance (6MWD) [ Time Frame: Baseline to day 60 ]
Central Contacts
- Mina S. Sedrak, MD310-825-3181
- Kelly Synold424-440-3877
Locations (7)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UCLA Health Cancer Care in Alhambra | Alhambra | California | 91801 | |
| UCLA Health Beverly Hills Primary & Specialty Care | Beverly Hills | California | 90210 | |
| UCLA Health Burbank Primary & Specialty Care | Burbank | California | 91505 | |
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010 | Lisa D. Yee, MD (PRINCIPAL_INVESTIGATOR) |
| UCLA / Jonsson Comprehensive Cancer Center | Los Angeles | California | 90095 | Mina S. Sedrak (PRINCIPAL_INVESTIGATOR) |
| UCLA Health Primary Care in Marina del Rey | Marina del Rey | California | 90292 | |
| UCLA Health Primary Care in Pasadena | Pasadena | California | 91105 |
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