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.
Women who are postmenopausal at the start of study treatment.
Women aged: >= 60 years OR
They have not had any menstrual periods for at least 12 months in the absence of exogenous hormonal treatments, chemotherapy, and/or tamoxifen AND have serum estradiol and follicle-stimulating hormone (FSH) levels confirmed as being within the standard laboratory reference range for postmenopausal females.
They have documented irreversible bilateral oophorectomy.
Cancer-directed chemotherapy, biological therapy, or immunotherapy within 30 days prior to the start of study treatment. Exceptions include: trastuzumab, pertuzumab, pembrolizumab, tamoxifen, ribociclib, abemaciclib, aromatase inhibitors and/or ovarian suppression.
Surgery and/or radiation within the last 30 days of starting study treatment (Exception: invasive non- major procedures such as an outpatient biopsy)
Subjects taking medications that are considered prohibited.
Exception: Subjects taking any of the medications listed in under "Temporary medication adjustment required" may participate if they are otherwise eligible AND the medication can be safely withheld (from immediately before the 1st study agent administration until at least 10 hours after the last study agent administration, for each dosing interval)
Parallel
Biospecimen Collection
Procedure/SurgeryUndergo collection of blood samples
Fisetin
DrugGiven PO
Placebo Administration
DrugGiven PO
Quality-of-Life Assessment
Other interventionAncillary studies
Questionnaire Administration
Other interventionAncillary studies
Change in 6-minute walk distance (6MWD)
The 6MWD is a validated measure of physical function. Participants walk at their own pace for 6 minutes and distance (in meters) is measured at the end. Will be treated as a continuous variable. Its distribution will be transformed to normality as appropriate, Initially, a simple t-test will be used to compare the means of 6MWD at Day 60 by treatment groups.
Change in grip strength
Generalized estimating equation (GEE) models will be fitted. The variables also will be dichotomized (e.g., \< median, \>= median) and GEE models for binary data used to access change in grip strength. Grip strength will be obtained using a hand dynamometer.
Change in Short Physical Performance Battery score
GEE models will be fitted. The variables also will be dichotomized (e.g., \< median, \>= median) and GEE models for binary data used to access change in short physical performance battery score.
Change in frailty phenotype
GEE models will be fitted. The variables also will be dichotomized (e.g., \< median, \>= median) and GEE models for binary data used to test treatment effects over time.
Change in physical function component of 36-item Short Form (SF-36)
GEE models will be fitted. The variables also will be dichotomized (e.g., \< median, \>= median) and GEE models for binary data used to test treatment effects over time.
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Jonsson Comprehensive Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
National Institute on Aging (NIA)
Collaborator
