Fisetin to Improve Physical Function in Stage I-III Breast Cancer Survivors
Start Date
3/27/2023
Completion Date
8/14/2028
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.
Detailed 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 Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20 \[QLQ-CIPN20\]). IV. To determine the effect of fisetin on cognitive function (Patient Reported Outcomes Measurement Information System \[PROMIS\] cognitive function short form). V. To determine the effect of fisetin on health-related quality of life (SF-36). VI. To determine the effect of fisetin on sleep (Insomnia Severity Index \[ISI\]). VII. To determine the effect of fisetin on anxiety (GAD-7). VIII. To determine the effect of fisetin on depression (PHQ-8). IX. To determine the effect of fisetin on local and distant recurrence free survival. X. To determine the effect of fisetin on breast cancer specific survival and overall survival. XI. To evaluate the safety and tolerability of fisetin (physician and patient-reported Common Terminology Criteria for Adverse Events \[CTCAEs\]). XII. To estimate rates of adherence to fisetin (pill diary). EXPLORATORY OBJECTIVES: I. To determine the effect of fisetin on p16 expression in peripheral CD3+ T-cells. II. To determine the effect of fisetin on circulating senescence-associated secretory phenotype (SASP) inflammatory factors. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive fisetin orally (PO) on days 1, 2, and 3. Treatment repeats every 2 weeks for up to 8 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples throughout the trial. ARM B: Patients receive placebo PO on the trial. on days 1, 2, and 3. Treatment repeats every 2 weeks for up to 8 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples throughout the trial. After completion of study treatment, patients are followed up yearly for up to 3 years.
Eligibility Criteria
Age Range: No minimum to No maximum
Interventions
Biospecimen Collection
Fisetin
Placebo Administration
Quality-of-Life Assessment
Questionnaire Administration
Conditions
Locations
UCLA Health Cancer Care in Alhambra
Alhambra, California 91801
United States
UCLA Health Beverly Hills Primary & Specialty Care
Beverly Hills, California 90210
United States
UCLA Health Burbank Primary & Specialty Care
Burbank, California 91505
United States
City of Hope Comprehensive Cancer Center
Duarte, California 91010
United States
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California 90095
United States
UCLA Health Primary Care in Marina del Rey
Marina del Rey, California 90292
United States
UCLA Health Primary Care in Pasadena
Pasadena, California 91105
United States