Fisetin + Exercise for Breast Cancer
(PROFFi Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial requires you to stop taking certain medications, especially those with senolytic properties like curcumin or St. John's wort, 2 days before and during the study. Some medications may need to be temporarily adjusted, and others are prohibited, so it's best to discuss your current medications with the study team.
What data supports the effectiveness of the treatment Fisetin + Exercise for Breast Cancer?
Is it safe to combine exercise with breast cancer treatment?
How is the Fisetin + Exercise treatment for breast cancer different from other treatments?
This treatment combines Fisetin, a natural compound found in fruits and vegetables, with an exercise program, which is unique because it targets both the biological and physical aspects of recovery. While exercise is known to help with fatigue and improve physical capacity in breast cancer patients, the addition of Fisetin may offer additional benefits due to its antioxidant properties.210111213
What is the purpose of this trial?
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.
Research Team
Mina S. Sedrak
Principal Investigator
UCLA / Jonsson Comprehensive Cancer Center
Eligibility Criteria
This trial is for postmenopausal women who have had early-stage breast cancer treated with chemotherapy within the last year. They should be in a pre-frail state but without active cancer or serious chronic illnesses. Participants must be able to swallow pills, not on certain medications, and not involved in other similar studies.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive fisetin or placebo orally on days 1-3 of each cycle, with treatment repeating every 14 days for 8 cycles. Exercise training or physical activity handouts are provided depending on the arm.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, with follow-up visits on days 120 and 180, and then annually for up to 3 years.
Treatment Details
Interventions
- Exercise Intervention
- Fisetin
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jonsson Comprehensive Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
National Institutes of Health (NIH)
Collaborator