A Phase II Randomized Placebo-Controlled Study of Fisetin and Exercise to Prevent Frailty in Breast Cancer Survivors
Jonsson Comprehensive Cancer Center
Summary
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.
Description
PRIMARY OBJECTIVE: I. To determine the effect of fisetin and/or exercise on physical function, as assessed using the 6-minute walk distance (6MWD), in chemotherapy-treated postmenopausal breast cancer survivors. SECONDARY OBJECTIVES: I. To determine the effect of fisetin and/or exercise on heart rate and step count, as measured by wearable device. II. To determine the effect of fisetin on other measures of physical function beyond 6MWD (short physical performance battery \[SPPB\], grip strength, frailty phenotype, physical activity). III. To determine the effect of fisetin and/or exercise…
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 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 eviden…
Interventions
- ProcedureBiospecimen Collection
Undergo collection of blood samples
- OtherEducational Intervention
Receive handout on physical activity
- OtherExercise Intervention
Receive individually tailored exercise intervention
- DrugFisetin
Given PO
- OtherPhysical Performance Testing
Ancillary studies
- DrugPlacebo Administration
Given PO
- OtherQuality-of-Life Assessment
Locations (6)
- UCLA Health Cancer Care in AlhambraAlhambra, California
- UCLA Health Beverly Hills Primary & Specialty CareBeverly Hills, California
- UCLA Health Burbank Primary & Specialty CareBurbank, California
- UCLA / Jonsson Comprehensive Cancer CenterLos Angeles, California
- UCLA Health Primary Care in Marina del ReyMarina del Rey, California
- UCLA Health Primary Care in PasadenaPasadena, California