A Phase II Randomized Double-Blind Placebo-Controlled Study of Fisetin to Improve Physical Function in Breast Cancer Survivors
Jonsson Comprehensive Cancer Center
Summary
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.
Description
PRIMARY OBJECTIVE: I. To determine the effect of fisetin on physical function, as assessed using the 6-minute walk distance (6MWD), in frail older breast cancer survivors. SECONDARY OBJECTIVES: I. To determine the effect of fisetin on other measures of physical function (grip strength, short physical performance battery \[SPPB\], frailty phenotype, physical function component of the 36 item short form survey \[SF-36\]). II. To determine the effect of fisetin on fatigability (Borg Rating of Perceived Exertion \[RPE\]). III. To determine the effect of fisetin on neuropathy (Quality of Life…
Eligibility
- Age range
- Not specified
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * 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…
Interventions
- ProcedureBiospecimen Collection
Undergo collection of blood samples
- DrugFisetin
Given PO
- DrugPlacebo Administration
Given PO
- OtherQuality-of-Life Assessment
Ancillary studies
- OtherQuestionnaire Administration
Ancillary studies
Locations (7)
- UCLA Health Cancer Care in AlhambraAlhambra, California
- UCLA Health Beverly Hills Primary & Specialty CareBeverly Hills, California
- UCLA Health Burbank Primary & Specialty CareBurbank, California
- City of Hope Comprehensive Cancer CenterDuarte, California
- UCLA / Jonsson Comprehensive Cancer CenterLos Angeles, California
- UCLA Health Primary Care in Marina del ReyMarina del Rey, California