Fasting + Exercise for Advanced Breast Cancer
(FastER Trial)
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Miami
Must be taking: CDK4/6 inhibitors
Disqualifiers: Oxygen dependent, Unstable cardiac disease, Insulin-dependent diabetes, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The purpose of this study is to test if four different programs (prolonged overnighting fasting alone, exercise alone, a combination of prolonged overnight fasting and exercise, or general health education sessions alone) can reduce fatigue in women with advanced or metastatic breast cancer who are receiving a medication called a cyclin-dependent kinases-4 and 6 (CDK4/6) inhibitor.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it does require that you are starting or have recently started a CDK4/6 inhibitor with endocrine therapy.
What data supports the effectiveness of the treatment Fasting + Exercise for Advanced Breast Cancer?
Preliminary findings suggest that combining intermittent fasting with endocrine therapy may improve treatment efficacy for hormone receptor-positive breast cancer. Additionally, supervised exercise during chemotherapy has been shown to improve health outcomes in breast cancer patients.
12345Is fasting and exercise safe for people with advanced breast cancer?
The safety of combining fasting and exercise for people with advanced breast cancer is not well-established, but fasting alone has shown potential to reduce chemotherapy side effects and protect healthy cells. Exercise is generally recommended for cancer patients to improve quality of life and physical function.
16789How is the Fasting + Exercise treatment for advanced breast cancer different from other treatments?
This treatment is unique because it combines prolonged overnight fasting with moderate-intensity exercise and general health education, which may enhance the effectiveness of existing therapies and reduce side effects, unlike traditional treatments that focus solely on medication or surgery.
110111213Eligibility Criteria
This trial is for postmenopausal women with advanced breast cancer who are starting or have recently started treatment with CDK4/6 inhibitors. They should not be regularly exercising vigorously, fasting overnight, or doing resistance training. Participants must be able to consent and understand English or Spanish.Inclusion Criteria
I am a woman.
My breast cancer is ER+ or PR+, HER-2-, and cannot be removed by surgery.
I am postmenopausal or using ovarian suppression.
+7 more
Exclusion Criteria
I cannot read or understand English or Spanish.
I am unable to give my consent.
I use insulin to manage my diabetes.
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo a 12-week program of prolonged overnight fasting, exercise, or general health education sessions, with health-related quality of life assessments and blood sample collection
12 weeks
Weekly sessions (in-person, telephone, or video call)
Follow-up
Participants are monitored for changes in sleep quality, body composition, physical function, toxicity, and various biomarkers
9 months
Assessments at 6 months and 12 months
Participant Groups
The study tests four approaches: prolonged overnight fasting, exercise, both combined, and general health education sessions to see if they reduce fatigue in women taking CDK4/6 inhibitors for advanced breast cancer.
4Treatment groups
Experimental Treatment
Active Control
Group I: Prolonged Overnighting Fasting Alone (POF Alone) GroupExperimental Treatment1 Intervention
Participants in this group will undergo a 12-week program of prolonged overnight fasting (POF), and weekly session with a trained health coach. Sessions may be delivered in-person, by telephone or by video call. Participants will also complete health-related quality of life questionnaires, and undergo blood sample collection at designated study timepoints.
Total participant duration is about 12 months.
Group II: Attention Control (AC) GroupExperimental Treatment1 Intervention
Participants in this group will receive other supportive care in the form of general health education sessions with a trained health coach. These bi-weekly sessions will be administered via telephone or video call in six (6) sessions over approximately 12 weeks. Participants will also complete health-related quality of life questionnaires at designated study timepoints.
Total participation is about 12 months.
Group III: Prolonged Overnight Fasting and Exercise (POF+EXE) GroupActive Control2 Interventions
Participants in this group will undergo a 12-week combined program of the prolonged overnight fasting and exercise interventions as described in the POF Alone and EXE Alone arm descriptions respectively. Participants will complete health-related quality of life questionnaires, and undergo blood sample collection at designated study timepoints.
Total participation is about 12 months.
Group IV: Exercise Alone (EXE Alone) GroupActive Control1 Intervention
Participants in this group will undergo a 12-week exercise program during three weekly sessions supervised by a trained health coach. Sessions may be delivered in-person, or virtually via telehealth. Participants will also complete health-related quality of life questionnaires, and undergo blood sample collection at designated study timepoints.
Total participant duration is about 12 months.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MiamiMiami, FL
Dana-Farber Cancer InstituteBoston, MA
Arizona State UniversityPhoenix, AZ
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Who Is Running the Clinical Trial?
University of MiamiLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Fasting May Complement Endocrine Therapy. [2021]Preliminary findings from a recent study suggest that combining intermittent fasting or a fasting-mimicking diet with endocrine therapy for hormone receptor-positive breast cancer may improve treatment efficacy and reduce side effects.
Feasibility of early multimodal interventions for elderly patients with advanced pancreatic and non-small-cell lung cancer. [2021]Combinations of exercise and nutritional interventions might improve the functional prognosis for cachectic cancer patients. However, high attrition and poor compliance with interventions limit their efficacy. We aimed to test the feasibility of the early induction of new multimodal interventions specific for elderly patients with advanced cancer Nutrition and Exercise Treatment for Advanced Cancer (NEXTAC) programme.
Effectiveness of Oncologist-Referred Exercise and Healthy Eating Programming as a Part of Supportive Adjuvant Care for Early Breast Cancer. [2019]Randomized trials have established efficacy of supervised exercise training during chemotherapy for breast cancer for numerous health outcomes. The purpose of this study was to assess reach, effectiveness, maintenance, and implementation of an evidence-based exercise and healthy eating program offered within an adjuvant care setting.
[The cost of the therapeutic education program "Eat better, move more through nutrition education" in patients with breast cancer]. [2020]Since the life expectancy of women with breast cancer has increased, tertiary prevention, through the Therapeutic Patient Education (TPE), is now a part of patient support. The main objective of this pilot study is to evaluate the cost of a nutrition and physical activity TPE program intended to help women with breast cancer in the management of their weight.
The Effect of Exercise and Nutritional Interventions on Body Composition in Patients with Advanced or Metastatic Cancer: A Systematic Review. [2022]Advanced and metastatic cancers significantly alter body composition, leading to decreased lean mass and variable effects on fat mass. These effects on body composition are associated with significant physical dysfunction and poor prognosis in patients with cancer. Whilst exercise and nutritional interventions are likely to be of benefit in counteracting these effects, relatively little is known about using such interventions in patients with advanced or metastatic cancer. Therefore, in this systematic review we examine the effect of exercise and combined exercise and nutritional interventions on lean mass and fat mass among patients diagnosed with advanced or metastatic cancer. Following PRISMA guidelines, we identified 20 articles from PubMed, EMBASE, CINAHL, Cochrane CENTRAL, PEDro, SPORTDiscus, and REHABDATA. Overall, advanced or metastatic cancer populations comprising of mixed cancer types were most commonly examined (n = 8) with exercise or combined exercise and nutritional interventions being well-tolerated with few adverse effects. Both intervention approaches may preserve lean mass, while only combined interventions may lead to alterations in fat mass. However, further exercise and nutritional studies are needed to definitively understand their effects on body composition. As exercise and nutrition-related research continues in this understudied population, the knowledge gained will help guide supportive clinical treatments.
Fasting and Exercise in Oncology: Potential Synergism of Combined Interventions. [2021]Nutrition and exercise interventions are strongly recommended for most cancer patients; however, much debate exists about the best prescription. Combining fasting with exercise is relatively untouched within the oncology setting. Separately, fasting has demonstrated reductions in chemotherapy-related side effects and improved treatment tolerability and effectiveness. Emerging evidence suggests fasting may have a protective effect on healthy cells allowing chemotherapy to exclusively target cancer cells. Exercise is commonly recommended and attenuates treatment- and cancer-related adverse changes to body composition, quality of life, and physical function. Given their independent benefits, in combination, fasting and exercise may induce synergistic effects and further improve cancer-related outcomes. In this narrative review, we provide a critical appraisal of the current evidence of fasting and exercise as independent interventions in the cancer population and discuss the potential benefits and mechanisms of combined fasting and exercise on cardiometabolic, body composition, patient-reported outcomes, and cancer-related outcomes. Our findings suggest that within the non-cancer population combined fasting and exercise is a viable strategy to improve health-related outcomes, however, its safety and efficacy in the oncology setting remain unknown. Therefore, we also provide a discussion on potential safety issues and considerations for future research in the growing cancer population.
Rationale and design of IMPACT-women: a randomised controlled trial of the effect of time-restricted eating, healthy eating and reduced sedentary behaviour on metabolic health during chemotherapy for early-stage breast cancer. [2023]Metabolic dysfunction and excess accumulation of adipose tissue are detrimental side effects from breast cancer treatment. Diet and physical activity are important treatments for metabolic abnormalities, yet patient compliance can be challenging during chemotherapy treatment. Time-restricted eating (TRE) is a feasible dietary pattern where eating is restricted to 8 h/d with water-only fasting for the remaining 16 h. The purpose of this study is to evaluate the effect of a multimodal intervention consisting of TRE, healthy eating, and reduced sedentary time during chemotherapy treatment for early-stage (I-III) breast cancer on accumulation of visceral fat (primary outcome), other fat deposition locations, metabolic syndrome and cardiovascular disease risk (secondary outcomes) compared with usual care. The study will be a two-site, two-arm, parallel-group superiority randomised control trial enrolling 130 women scheduled for chemotherapy for early-stage breast cancer. The intervention will be delivered by telephone, including 30-60-minute calls with a registered dietitian who will provide instructions on TRE, education and counselling on healthy eating, and goal setting for reducing sedentary time. The comparison group will receive usual cancer and supportive care including a single group-based nutrition class and healthy eating and physical activity guidelines. MRI, blood draws and assessment of blood pressure will be performed at baseline, after chemotherapy (primary end point), and 2-year follow-up. If our intervention is successful in attenuating the effect of chemotherapy on visceral fat accumulation and cardiometabolic dysfunction, it has the potential to reduce risk of cardiometabolic disease and related mortality among breast cancer survivors.
Reducing breast cancer recurrence with weight loss, a vanguard trial: the Exercise and Nutrition to Enhance Recovery and Good Health for You (ENERGY) Trial. [2021]Breast cancer is the most common invasive cancer among women in developed countries. Obesity is a major risk factor for breast cancer recurrence and mortality in both pre- and postmenopausal women. Co-morbid medical conditions are common among breast cancer survivors. The Exercise and Nutrition to Enhance Recovery and Good Health for You (ENERGY) study is a 4-year randomized clinical trial of 693 overweight/obese women aged ≥21years diagnosed with any early stage breast cancer (stages I[≥1cm]-III) within the previous five years, designed to demonstrate the feasibility of achieving sustained weight loss and to examine the impact of weight loss on quality of life and co-morbidities, and to enable future exploration of biochemical mechanisms linking obesity to lower likelihood of disease-free survival. This trial is strategically designed as a vanguard for a fully-powered trial of women who will be evaluated for breast cancer recurrence and disease-free survival. Participants were recruited between 2010 and 2012 at four sites, had completed initial therapies, and had a body mass index between 25 and 45kg/m(2). The intervention featured a group-based cognitive-behavioral weight loss program with telephone counseling and tailored newsletters to support initial weight loss and subsequent maintenance, with the goal of 7% weight loss at two years. This study has high potential to have a major impact on clinical management and outcomes after a breast cancer diagnosis. This trial initiates the effort to establish weight loss support for overweight or obese breast cancer survivors as a new standard of clinical care.
Results of the Exercise and Nutrition to Enhance Recovery and Good Health for You (ENERGY) Trial: A Behavioral Weight Loss Intervention in Overweight or Obese Breast Cancer Survivors. [2019]Obesity increases risk for all-cause and breast cancer mortality and comorbidities in women who have been diagnosed and treated for breast cancer. The Exercise and Nutrition to Enhance Recovery and Good Health for You (ENERGY) study is the largest weight loss intervention trial among survivors of breast cancer to date.
Fasting during cancer treatment: a systematic review. [2023]Clinical data on the modern topic fasting among cancer patients are rare. This review aimed to summarise published clinical data on fasting and its effects on patients undergoing chemotherapy and therefore to give some directions in advising patients with the desire to fast.
Results of a diet/exercise feasibility trial to prevent adverse body composition change in breast cancer patients on adjuvant chemotherapy. [2021]Patients with breast cancer on adjuvant chemotherapy can experience weight gain and concurrent losses in muscle mass. Exercise interventions can prevent these changes, but time and travel pose barriers to participation. The Survivor Training for Enhancing Total Health (STRENGTH) trial assessed the feasibility and impact of 2 home-based interventions.
Effect of a diet and physical activity intervention on body weight and nutritional patterns in overweight and obese breast cancer survivors. [2021]Energy restriction from a low-calorie diet and increased energy expenditure induced by physical activity (PA) could promote weight loss/maintenance and be important determinants of breast cancer (BC) prognosis. The aim of this study was to assess participation and adherence of overweight and obese BC survivors to a lifestyle intervention and to demonstrate the capacity of this intervention to induce weight loss and nutritional changes. This single-arm pre-post study, which involved one-hourly weekly diet sessions delivered by a dietician and 75-min bi-weekly PA sessions of moderate-to-high intensity led by PA monitors, was offered to overweight and obese BC survivors shortly after treatment. Before and after the intervention, anthropometry, dietary information, quality of life (QoL) and cardiorespiratory fitness (CRF) were collected. A total of 112 BC survivors were invited to participate: 42 of them started the intervention and 37 completed it. Participants attended more than 90 % of the sessions offered and showed a significant weight loss of 5.6 ± 2.0 kg, as well as significant decreases in body mass index, fat mass and waist circumference. Significant decreases in total energy (-25 %), fat (-35 %), saturated fat (-37 %) and carbohydrate (-21 %) intakes were observed while QoL and CRF showed significant increases. This feasibility study demonstrated the success of a short-term diet and PA intervention to induce weight loss and promote healthful changes in BC survivors. Assessing the long-term effects of these changes, and in particular their possible impact of BC prognosis, and designing interventions reaching a wider number of BC survivors are still issues to be addressed.
A case study: prescriptive exercise intervention after bilateral mastectomies. [2004]Exercise for cancer patients is gaining support. In the current case study, a female breast cancer patient was diagnosed with breast cancer at the age of 29 years; she underwent a left modified radical mastectomy. She developed cancer again in the opposite breast at the age of 57 years and had a right modified radical mastectomy. After the second mastectomy (the right breast), the patient received chemotherapy and radiation. Following her cancer treatments, she participated in an exercise intervention for 6 months at the University of Northern Colorado's Rocky Mountain Cancer Rehabilitation Institute. A 6-month reassessment showed that she increased her muscular strength and cardiovascular function in addition to attenuating her cancer-related fatigue and depression. It is recommended that health professionals work together to ensure that a collaborative effort is undertaken to increase functional work capacity that will significantly improve patients' quality of life.