This phase II trial tests how well fisetin and exercise works in preventing frailty in breast cancer survivors. Fisetin is a natural substance found in strawberries and other foods and is available as a nutritional supplement. Nutritional supplements may be useful in eliminating 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 cause inflammation and damage nearby healthy cells. Giving fisetin may eliminate senescent cells in patients with breast cancer undergoing physical activity.
Women who are postmenopausal at the start of study treatment
Postmenopausal status will be established as follows: Women who are 50 years or older and who are not menstruating for greater than 12 months will be considered postmenopausal. Women who are less than 50 years with an intact uterus and ovaries must have chemically induced menopause (e.g., ovarian suppression) to be considered postmenopausal
Women with a diagnosis of early-stage breast cancer (stage I, II, III) treated with neo/adjuvant chemotherapy within 12 months of starting study treatment
No evidence of active/recurrent breast cancer or other serious chronic illnesses
Cancer-directed chemotherapy, biological therapy, or immunotherapy within 30 days prior to the start of study treatment. Exceptions include: trastuzumab, pertuzumab, pembrolizumab, tamoxifen, and aromatase inhibitors
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 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
Educational Intervention
Other interventionReceive handout on physical activity
Exercise Intervention
Other interventionReceive individually tailored exercise intervention
Fisetin
DrugGiven PO
Physical Performance Testing
Other interventionAncillary studies
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 will assess the distance walked over 6 minutes and is measured in meters. A linear model will be fit to outcome variable (change score) with a factor variable representing the four study arms and control for baseline 6MWD, site, and age stratum. The analysis will be conducted as intention-to-treat analysis. Will conduct an as-treated analysis, comparing the treatments received (instead of as-randomized).
Change in heart rate
Changes will be calculated for treatments A, B, AB, and C. Linear models will be used to determine treatment effects using the two-stage testing procedure. Will conduct as-treated analysis and linear mixed models will also be fit to examine trends.
Change in step count
Changes will be calculated for treatments A, B, AB, and C. Linear models will be used to determine treatment effects using the two-stage testing procedure. Will conduct as-treated analysis and linear mixed models will also be fit to examine trends.
Change in short physical performance battery (SPPB)
Changes will be calculated for treatments A, B, AB, and C. Linear models will be used to determine treatment effects using the two-stage testing procedure. Will conduct as-treated analysis and linear mixed models will also be fit to examine trends.
Change in grip strength
Changes will be calculated for treatments A, B, AB, and C. Linear models will be used to determine treatment effects using the two-stage testing procedure. Will conduct as-treated analysis and linear mixed models will also be fit to examine trends.
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Jonsson Comprehensive Cancer Center
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Cancer Institute (NCI)
Collaborator
Rising Tide Foundation
Collaborator
