Fisetin + Exercise for Breast Cancer
(PROFFi Trial)
Recruiting in Palo Alto (17 mi)
+5 other locations
Age: Any Age
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Jonsson Comprehensive Cancer Center
Must not be taking: Senolytics, Anticoagulants, Herbal supplements
Disqualifiers: Active cancer, Surgery, Radiation, others
No Placebo Group
Prior Safety Data
Trial Summary
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.
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.
12345Is 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.
46789How 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.
210111213Eligibility 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.
+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.
+6 more
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
UCLA Health Cancer Care in AlhambraAlhambra, CA
UCLA Health Beverly Hills Primary & Specialty CareBeverly Hills, CA
UCLA Health Burbank Primary & Specialty CareBurbank, CA
UCLA Health Primary Care in Marina del ReyMarina del Rey, CA
More Trial Locations
Loading ...
Who Is Running the Clinical Trial?
Jonsson Comprehensive Cancer CenterLead Sponsor
National Cancer Institute (NCI)Collaborator
National Institutes of Health (NIH)Collaborator
References
Bootcamp during neoadjuvant chemotherapy for breast cancer: a randomized pilot trial. [2021]Exercise may improve cancer outcomes. Neoadjuvant chemotherapy (NC) for breast cancer provides a unique setting to evaluate intervention effects. Treatments leading to decreased post-neoadjuvant Ki-67 levels, smaller tumor size, and higher pathologic response are associated with improved survival and lower recurrence. This randomized, prospective pilot trial evaluates the feasibility of supervised exercise during NC for breast cancer.
Predictors of adherence to different types and doses of supervised exercise during breast cancer chemotherapy. [2021]Exercise is beneficial for breast cancer patients during chemotherapy but adherence to different types and doses of exercise is a challenge. The purpose of this study was to examine predictors of adherence to different types and doses of exercise during breast cancer chemotherapy in a multicenter randomized controlled trial.
Exercise and cancer recovery. [2018]Disease and cancer treatment-related side effects such as decreased energy level, muscle weakness, and declines in functional status and body mass have been well documented. There is evidence that exercise, such as low intensity aerobics walking, Tai Chi, or cycling, results in an overall decrease in fatigue levels over the course of cancer treatment. Additionally, there is evidence that regular physical activity or exercise can decrease emotional stress, blood pressure, the duration of neutropenia, thrombocytopenia, and pain. Exercise also has been shown to increase quality of life and improve the maximal oxygen uptake during exertion, sleep patterns, and cognition. However, the majority of studies of exercise and cancer have been conducted with women with early stage breast cancer, limiting the generalizability of these studies to other cancer populations. The purpose of this systematic review is to provide a synthesis of the extant research evidence about th e benefits of exercise related to cancer recovery.
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]The Combined Aerobic and Resistance Exercise (CARE) Trial compared different types and doses of exercise performed during breast cancer chemotherapy. Here, we report the longer-term follow-up of patient-reported outcomes, health-related fitness and exercise behavior at 6, 12 and 24 months postintervention. A multicenter trial in Canada randomized 301 breast cancer patients initiating chemotherapy to thrice weekly, supervised exercise consisting of a standard dose of 25-30 min of aerobic exercise (STAN; n = 96), a higher dose of 50-60 min of aerobic exercise (HIGH; n = 101) or a combined dose of 50-60 min of aerobic and resistance exercise (COMB; n = 104) performed for the duration of chemotherapy (median of 17 weeks). Primary outcomes were patient-reported outcomes including quality of life, cancer-related symptoms and psychosocial outcomes. Secondary outcomes were objective health-related fitness (assessed at 12 months only) and self-reported exercise behavior. A total of 269 (89.4%) participants completed patient-reported outcomes at all three follow-up time points and 263 (87.4%) completed the health-related fitness assessment at 12-month follow-up. COMB was significantly superior to (i) STAN for sleep quality at 6-month follow-up (p = 0.027); (ii) HIGH for upper body muscular endurance at 12-month follow-up (p = 0.020); and (iii) HIGH for meeting the resistance exercise guideline at 6-month follow-up (p = 0.006). Moreover, self-reported meeting of the combined exercise guideline during follow-up was significantly associated with better patient-reported outcomes and health-related fitness. Performing combined exercise during and after breast cancer chemotherapy may result in better longer-term patient-reported outcomes and health-related fitness compared to performing aerobic exercise alone.
High intensity exercise during breast cancer chemotherapy - effects on long-term myocardial damage and physical capacity - data from the OptiTrain RCT. [2021]Label="BACKGROUND" NlmCategory="BACKGROUND">Adjuvant systemic breast cancer treatment improves disease specific outcomes, but also presents with cardiac toxicity. In this post-hoc exploratory analysis of the OptiTrain trial, the effects of exercise on cardiotoxicity were monitored by assessing fitness and biomarkers over the intervention and into survivorship. Methods; Women starting chemotherapy were randomized to 16-weeks of resistance and high-intensity interval training (RT-HIIT), moderate-intensity aerobic and high-intensity interval training (AT-HIIT), or usual care (UC). Outcome measures included plasma troponin-T (cTnT), Nt-pro-BNP and peak oxygen uptake (VO2peak), assessed at baseline, post-intervention, and at 1- and 2-years.
Short- and long-term impact of adapted physical activity and diet counseling during adjuvant breast cancer therapy: the "APAD1" randomized controlled trial. [2020]Patients with breast cancer undergoing chemotherapy and radiotherapy experience fatigue and other treatment side effects. Integrative therapies combining physical activity and dietary counseling are recommended; however to date no large randomized controlled trial has been conducted during adjuvant therapy. The Adapted Physical Activity and Diet (APAD) intervention was evaluated for its ability to decrease fatigue (primary outcome), anxiety, depression, body mass index (BMI), and fat mass, and enhance muscular and cognitive performances, and quality-of-life (QoL).
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]Few studies have systematically evaluated the risk of adverse events (AEs) among persons exercising during oncological treatment. We aimed to describe incidence and types of AEs during exercise for persons undergoing oncological treatment, and associations to exercise intensity, exercise adherence, chemotherapy treatment, initial aerobic fitness. A second aim was to compare incidence of lymphedema, periphery inserted central catheter (PICC) complications, and other new medical conditions (any illness or injury occurred during the exercise trial) between high-intensity vs low-to-moderate exercise and usual care (UC).
Treatment-Induced Cardiotoxicity in Breast Cancer: A Review of the Interest of Practicing a Physical Activity. [2019]Physical activity is known to prevent the occurrence of cancer and decrease the risk of breast cancer. At diagnosis of breast cancer, fewer than half of the patients reach the international recommendation for physical activity. However, breast cancer patients, and particularly HER2+ breast cancer patients, are exposed to treatment-induced cardiotoxicity because of a side effect of 2 molecules used in standard therapy to treat these tumors, i.e., anthracycline and trastuzumab. Cardiotoxicity can sometimes lead to discontinuation of the treatment and even to the development of cardiovascular diseases. Exercise is known to protect the cardiovascular system in the healthy population. Consequently, being physically active during treatment appears to be a way to prevent the negative impact of cancer treatment on the heart in this population. In particular, aerobic exercising could have a protective effect against treatment-induced cardiotoxicity. A supervised physical activity program seems to be the best way for breast cancer patients to be active during treatment. However, there is very little information, and in particular a lack of guidelines, on exercising available to patients. The interventional trials that have been conducted on this topic are very heterogeneous and no standard recommendations have been made available for cancer patients thus far. An effective physical activity program needs to take each patient's barriers and motivations into account in order to encourage the practice of physical activity throughout treatment. To ensure the success of the program, it is essential to facilitate adherence and especially maintain motivation. Further studies are needed to determine what practice guidelines oncologists should give their patients.
Highly favorable physiological responses to concurrent resistance and high-intensity interval training during chemotherapy: the OptiTrain breast cancer trial. [2019]Advanced therapeutic strategies are often accompanied by significant adverse effects, which warrant equally progressive countermeasures. Physical exercise has proven an effective intervention to improve physical function and reduce fatigue in patients undergoing chemotherapy. Effects of high-intensity interval training (HIIT) in this population are not well established although HIIT has proven effective in other clinical populations. The aim of the OptiTrain trial was to examine the effects of concurrent resistance and high-intensity interval training (RT-HIIT) or concurrent moderate-intensity aerobic and high-intensity interval training (AT-HIIT), to usual care (UC) on pain sensitivity and physiological outcomes in patients with breast cancer during chemotherapy.
Feasibility and effects of a combined adjuvant high-intensity interval/strength training in breast cancer patients: a single-center pilot study. [2018]To evaluate feasibility of an exercise intervention consisting of high-intensity interval endurance and strength training in breast cancer patients.
Home-based exercise to alleviate fatigue and improve functional capacity among breast cancer survivors. [2022]This pilot study examined the efficacy of two home-based exercise programs on alleviating fatigue and improving functional capacity in breast cancer survivors. Participants were randomly assigned into one of three groups: aerobic exercise (AE), resistance exercise (RE), or usual care control (CON). After receiving individualized instruction and training, participants assigned to the AE and RE groups were asked to perform the prescribed exercise(s) 3 times per week for 12 weeks at home. Both groups were instructed to keep their perceived exercise intensity in the "fairly light" to "somewhat hard" range using the Borg Perceived Exertion Scale. All participants completed the revised Piper Fatigue Scale (PFS) and the 6-minute walk test (6MWT) at baseline and 12-week post-exercise program. Analysis of pre- and post-training data revealed a significant reduction in fatigue levels on the PFS among participants in the AE group (Z=2.521, one-tailed P=0.006), and a significant improvement in the distance of the 6MWT for the RE group (Z=2.366, one-tailed P=0.009) at the end of 12-week study period. No significant changes in fatigue or functional status were observed in the CON group. Findings provide preliminary support for RE as a viable strategy for improving functional capacity in breast cancer survivors, while AE may be more effective in attenuating cancer-related fatigue. Incorporating RE training for future research may help advance the growing body of knowledge in symptom management for breast cancer survivors.
High-intensity interval training in breast cancer survivors: a systematic review. [2021]To review the settings and outcomes of high-intensity interval training (HIIT) interventions for breast cancer survivors, and to explore the feasibility of prescribing exercise for breast cancer survivors.
Effects of a short-term differently dosed aerobic exercise on maximum aerobic capacity in breast cancer survivors: a pilot study. [2022]Regular physical activity and exercise improves quality of life and possibly reduces risk of disease relapse and prolongs survival in breast cancer survivors. The aim of this study was to evaluate the impact of a 3-week moderate intensity aerobic training, on aerobic capacity (VO2max) in breast cancer survivors.