A Phase II Randomized Double-Blind Placebo-Controlled Study of Fisetin to Improve Physical Function in Breast Cancer Survivors
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.
⁃ Postmenopausal status will be established as follows:
• Women aged: \>= 60 years OR
• Women aged \< 60 years AND one of the following conditions is met:
‣ 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.
⁃ They are receiving ovarian suppression with their breast cancer endocrine therapy
• Women with a diagnosis of early-stage breast cancer (Stage I-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
∙ Have evidence of frail health, defined as a diminished 6-minute walk distance (\< 400m) at baseline
∙ Platelets \> 60,000/mm\^3
∙ White blood cell count \> 2,000/mm\^3
∙ Absolute neutrophil count \> 500/mm\^3
∙ Hemoglobin \>= 8.0 g/dL
∙ Total bilirubin =\< 3.0 X upper limit of normal (ULN)
∙ Aspartate aminotransferase (AST) =\< 4.0 x ULN
∙ Alanine aminotransferase (ALT) =\< 4.0 x ULN
∙ Estimated glomerular filtration rate (eGFR) of \>= 30mL/min/1.73m\^2 per the Modification of Diet in Renal Disease (MDRD) calculation
∙ Ability to understand and the willingness to sign a written informed consent document