NCT05595499

Fisetin to Improve Physical Function in Stage I-III Breast Cancer Survivors

A Phase II Randomized Double-Blind Placebo-Controlled Study of Fisetin to Improve Physical Function in Breast Cancer Survivors

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Anatomic Stage I Breast Cancer AJCC v8
• Anatomic Stage II Breast Cancer AJCC v8
• Anatomic Stage III Breast Cancer AJCC v8

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo collection of blood samples
DRUG	Fisetin	Given PO
DRUG	Placebo Administration	Given PO
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2023-03-27
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2022-10-27
• Last updated: 2025-07-02

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study