164 Participants Needed

Fisetin + Exercise for Breast Cancer

(PROFFi Trial)

Recruiting at 5 trial locations
MS
KS
Overseen ByKelly Synold
Age: Any Age
Sex: Female
Trial Phase: Phase 2
Sponsor: Jonsson Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human 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?

Research shows that exercise during breast cancer treatment can improve quality of life, reduce fatigue, and enhance physical fitness. Combining aerobic and resistance exercise during chemotherapy has been linked to better long-term health outcomes and improved sleep quality.12345

Is it safe to combine exercise with breast cancer treatment?

Exercise during breast cancer treatment is generally safe and can improve physical function and reduce fatigue. It may also protect the heart from treatment-related side effects, although more research is needed to establish specific guidelines.46789

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

MS

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

I am a woman treated for early-stage breast cancer with chemotherapy in the last 12 months.
I don't have active breast cancer or other serious long-term illnesses.
I can walk between 400 to 480 meters in 6 minutes.
See 10 more

Exclusion Criteria

I am not taking any medications that are not allowed in the study.
I am taking herbal medications that I cannot stop for the study, except for CBD, vitamins, probiotics, and fish oil.
I am on blood thinners like warfarin or heparin.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

16 weeks
3 visits per week for exercise training (in-person)

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.

3 years
2 visits (in-person) initially, then annual visits

Treatment Details

Interventions

  • Exercise Intervention
  • Fisetin
Trial Overview The PROFFi trial is testing if fisetin (a natural substance) combined with exercise can prevent frailty in breast cancer survivors by eliminating aged cells that may damage healthy ones. The study includes physical tests, biospecimen collection, educational sessions, and quality-of-life assessments.
Participant Groups
4Treatment groups
Experimental Treatment
Active Control
Group I: Arm AB (fisetin, tailored exercise training)Experimental Treatment6 Interventions
Patients receive fisetin PO on days 1-3 of each cycle. Treatment repeats every 14 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive individually tailored supervised exercise training consisting of 30-45 minutes of aerobic training and 20-30 minutes of resistance training three times a week over 16 weeks. Patients undergo collection of blood samples on study.
Group II: Arm A (fisetin, physical activity handout)Active Control6 Interventions
Patients receive fisetin PO on days 1-3 of each cycle. Treatment repeats every 14 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive handout on the importance of physical activity during baseline. Patients undergo collection of blood samples on study.
Group III: Arm B (placebo, tailored exercise training)Active Control6 Interventions
Patients receive placebo PO on days 1-3 of each cycle. Treatment repeats every 14 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive individually tailored supervised exercise training consisting of 30-45 minutes of aerobic training and 20-30 minutes of resistance training three times a week over 16 weeks. Patients undergo collection of blood samples on study.
Group IV: Arm C (placebo, physical activity handout)Active Control6 Interventions
Patients receive placebo PO on days 1-3 of each cycle. Treatment repeats every 14 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive handout on the importance of physical activity during baseline. Patients undergo collection of blood samples on study.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials
373
Recruited
35,200+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

Findings from Research

In a pilot trial involving 10 breast cancer patients undergoing neoadjuvant chemotherapy, adding a supervised exercise program resulted in a significant decrease in body mass index (BMI) compared to those receiving chemotherapy alone (28.0 vs. 35.8, P = 0.03).
While the exercise group showed a trend towards lower Ki-67 levels (7% vs. 29%, P = 0.14), indicating potential benefits in tumor proliferation rates, the difference was not statistically significant, suggesting further research is needed to confirm these findings.
Bootcamp during neoadjuvant chemotherapy for breast cancer: a randomized pilot trial.Rao, R., Cruz, V., Peng, Y., et al.[2021]
In a study of 301 breast cancer patients undergoing chemotherapy, overall adherence to supervised exercise sessions was 73%, with significant predictors including location, fewer endocrine symptoms, and the type of exercise prescribed.
Patients with earlier stages of cancer (I/IIa) adhered well to all exercise types, while those with more advanced stages (IIb/III) showed better adherence to a standard dose of aerobic exercise, indicating that exercise prescription should be tailored based on disease stage and individual characteristics.
Predictors of adherence to different types and doses of supervised exercise during breast cancer chemotherapy.Courneya, KS., Segal, RJ., Gelmon, K., et al.[2021]
Exercise, including low-intensity activities like walking and Tai Chi, significantly reduces fatigue and improves overall quality of life for cancer patients during treatment, as shown in a systematic review of existing research.
While exercise benefits are well-documented, most studies focus on women with early-stage breast cancer, suggesting that more research is needed to understand its effects on other cancer populations.
Exercise and cancer recovery.Visovsky, C., Dvorak, C.[2018]

References

Bootcamp during neoadjuvant chemotherapy for breast cancer: a randomized pilot trial. [2021]
Predictors of adherence to different types and doses of supervised exercise during breast cancer chemotherapy. [2021]
Exercise and cancer recovery. [2018]
Effects of exercise dose and type during breast cancer chemotherapy on longer-term patient-reported outcomes and health-related fitness: A randomized controlled trial. [2020]
High intensity exercise during breast cancer chemotherapy - effects on long-term myocardial damage and physical capacity - data from the OptiTrain RCT. [2021]
Short- and long-term impact of adapted physical activity and diet counseling during adjuvant breast cancer therapy: the "APAD1" randomized controlled trial. [2020]
Is it safe to exercise during oncological treatment? A study of adverse events during endurance and resistance training - data from the Phys-Can study. [2021]
Treatment-Induced Cardiotoxicity in Breast Cancer: A Review of the Interest of Practicing a Physical Activity. [2019]
Highly favorable physiological responses to concurrent resistance and high-intensity interval training during chemotherapy: the OptiTrain breast cancer trial. [2019]
Feasibility and effects of a combined adjuvant high-intensity interval/strength training in breast cancer patients: a single-center pilot study. [2018]
11.United Statespubmed.ncbi.nlm.nih.gov
Home-based exercise to alleviate fatigue and improve functional capacity among breast cancer survivors. [2022]
High-intensity interval training in breast cancer survivors: a systematic review. [2021]
Effects of a short-term differently dosed aerobic exercise on maximum aerobic capacity in breast cancer survivors: a pilot study. [2022]
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