Prevention of Frailty With Fisetin and Exercise in Breast Cancer Survivors

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.

Conditions

• Anatomic Stage I Breast Cancer American Joint Committee on Cancer (AJCC) v8
• Anatomic Stage II Breast Cancer AJCC v8
• Anatomic Stage III Breast Cancer AJCC v8
• Early Stage Breast Carcinoma

Interventions

PROCEDURE

Biospecimen Collection

Undergo collection of blood samples

OTHER

Educational Intervention

Receive handout on physical activity

OTHER

Exercise Intervention

Receive individually tailored exercise intervention

DRUG

Fisetin

Given PO

OTHER

Physical Performance Testing

Ancillary studies

DRUG

Placebo Administration

Given PO

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• National Cancer Institute (NCI)

  collaborator NIH

• Rising Tide Foundation

  collaborator OTHER

• Jonsson Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Mina S Sedrak · UCLA / Jonsson Comprehensive Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-07-23

Primary Completion

2028-06-30

Completion

2028-12-30

FDA Drug

Yes

Countries

• United States

Study Locations