Fasting + Exercise for Advanced Breast Cancer

(FastER Trial)

Recruiting at 2 trial locations

Overseen By Tracy E Crane, PhD, RDN

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Miami

Must be taking: CDK4/6 inhibitors

Disqualifiers: Oxygen dependent, Unstable cardiac disease, Insulin-dependent diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

260 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if certain lifestyle changes can reduce fatigue in women with advanced or metastatic breast cancer. Participants will join one of four groups: prolonged overnight fasting (also known as intermittent fasting or time-restricted eating), moderate-intensity exercise (including structured exercise, resistance training, or cardio exercise), a combination of both, or general health education (also referred to as supportive care). The trial targets women who began a specific breast cancer treatment involving CDK4/6 inhibitors, such as palbociclib, within the last 90 days and have not been regularly fasting or exercising. As an unphased trial, this study provides a unique opportunity to explore lifestyle changes that could enhance well-being during treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research suggests that women who fast for 13 hours or more overnight might have a lower risk of breast cancer recurrence. However, specific evidence about the safety of fasting for women with advanced breast cancer is lacking. Generally, fasting for long periods is considered safe, but individual experiences can vary.

Studies have shown that moderate exercise is safe for breast cancer patients and can improve survival rates. Regular exercise helps reduce the chance of cancer recurrence and can lower the risk of death. Research consistently finds that women with breast cancer tolerate exercise well.

Both prolonged fasting and moderate exercise appear safe, but personal health conditions and treatments can affect individual experiences. Always consult a healthcare provider before starting any new health program. ^{1 2 3 4 5}

Why are researchers excited about this trial's programs?

Researchers are excited about this trial because it explores the potential benefits of lifestyle interventions, like fasting and exercise, for advanced breast cancer, which differ from traditional treatments such as chemotherapy and hormone therapy. Unlike standard medical treatments that primarily target cancer cells directly, this trial investigates how prolonged overnight fasting might influence cancer progression by altering metabolic processes and inflammation. Additionally, the integration of moderate-intensity exercise aims to enhance physical fitness and potentially improve quality of life. This approach is unique because it focuses on non-pharmacological strategies that could complement existing treatments, offering a holistic way to support overall well-being in patients.

What evidence suggests that this trial's programs could be effective in reducing fatigue for women with advanced breast cancer?

This trial will compare different interventions for advanced breast cancer. Research has shown that fasting for 13 hours or more at night, as practiced by participants in the Prolonged Overnight Fasting Alone (POF Alone) Group, might lower the risk of breast cancer recurrence. Studies suggest that this type of overnight fasting is linked to better health outcomes for breast cancer patients. Participants in the Exercise Alone (EXE Alone) Group will engage in moderate activities, which can improve well-being and reduce fatigue. Exercise is also associated with a lower risk of cancer recurrence and increased longevity. The Prolonged Overnight Fasting and Exercise (POF+EXE) Group will combine both interventions, which might enhance these benefits, though further research is needed to confirm this. ^{1 3 5 6 7}

Who Is on the Research Team?

Tracy E Crane, PhD, RDN

Principal Investigator

University of Miami

Carmen Calfa, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

I cannot read or understand English or Spanish.

I am unable to give my consent.

I use insulin to manage my diabetes.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• General Health Education Sessions
• Moderate-Intensity Exercise
• Prolonged Overnight Fasting

Trial Overview 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.

How Is the Trial Designed?

Group I: Prolonged Overnighting Fasting Alone (POF Alone) Group Experimental Treatment 1 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) Group Experimental Treatment 1 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) Group Active Control 2 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) Group Active Control 1 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.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The STRENGTH trial involving 90 premenopausal breast cancer patients on chemotherapy demonstrated that home-based diet and exercise interventions can help prevent weight gain and preserve lean body mass during treatment.

The combination of a calcium-rich diet, exercise, and a high fruit and vegetable, low-fat diet led to a significant reduction in body fat percentage compared to the control group, highlighting the potential for dietary and exercise strategies to improve body composition in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of a diet/exercise feasibility trial to prevent adverse body composition change in breast cancer patients on adjuvant chemotherapy. Demark-Wahnefried, W., Case, LD., Blackwell, K., et al.[2021]

A lifestyle intervention involving diet and physical activity led to significant weight loss (5.6 kg) and improvements in body composition among 37 overweight and obese breast cancer survivors who completed the program.

Participants showed substantial reductions in energy and fat intake, along with improvements in quality of life and cardiorespiratory fitness, indicating the intervention's effectiveness in promoting healthier lifestyles post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a diet and physical activity intervention on body weight and nutritional patterns in overweight and obese breast cancer survivors. Travier, N., Fonseca-Nunes, A., Javierre, C., et al.[2021]

A pilot study evaluated the costs of a nutrition and physical activity program for 65 women with breast cancer, showing an average cost of 541.04€ per patient over two years, which helps inform pricing and organization of such programs.

The study highlights the importance of direct costs, particularly the unit cost of the dietician, in determining the overall expenses of the Therapeutic Patient Education program aimed at managing weight in breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The cost of the therapeutic education program "Eat better, move more through nutrition education" in patients with breast cancer]. El Khal, M., Perrier, L., Carretier, J., et al.[2020]

This study will evaluate the effectiveness of a multimodal intervention combining time-restricted eating, healthy eating, and reduced sedentary time during chemotherapy in 130 women with early-stage breast cancer, focusing on reducing visceral fat accumulation and improving metabolic health.

If successful, the intervention could significantly lower the risk of cardiometabolic diseases and related mortality in breast cancer survivors, highlighting the importance of dietary and lifestyle modifications during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Christensen, RAG., Haykowsky, MJ., Nadler, M., et al.[2023]

The ENERGY study is a 4-year clinical trial involving 693 overweight or obese women with early-stage breast cancer, aimed at demonstrating the feasibility of sustained weight loss and its impact on quality of life and co-morbidities.

The trial's intervention includes a cognitive-behavioral weight loss program, which could establish weight loss support as a new standard of care for breast cancer survivors, potentially improving their clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing breast cancer recurrence with weight loss, a vanguard trial: the Exercise and Nutrition to Enhance Recovery and Good Health for You (ENERGY) Trial. Rock, CL., Byers, TE., Colditz, GA., et al.[2021]

The ENERGY study, involving 692 overweight/obese women who were about 2 years post-treatment for early-stage breast cancer, demonstrated that a structured behavioral weight loss intervention led to a significant mean weight loss of 6.0% at 12 months compared to only 1.5% in the control group.

The intervention not only resulted in meaningful weight loss but also improved physical activity and blood pressure, particularly benefiting women over 55 years old, highlighting the potential for such programs to enhance health outcomes in breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Rock, CL., Flatt, SW., Byers, TE., et al.[2019]

Preliminary findings indicate that combining intermittent fasting or a fasting-mimicking diet with endocrine therapy may enhance the effectiveness of treatment for hormone receptor-positive breast cancer.

This combination approach could also help in reducing side effects associated with the endocrine therapy, suggesting a potential strategy for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fasting May Complement Endocrine Therapy. [2021]

The NExT program, which included supervised exercise and healthy eating for women undergoing chemotherapy for breast cancer, was safe and effective, with 78% of participants completing the program and significant increases in moderate-to-vigorous physical activity (MVPA) during and after treatment.

Participants experienced lasting improvements in health-related quality of life (HRQoL) one year after the program, indicating that the exercise and nutrition intervention had a sustained positive impact on their well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Oncologist-Referred Exercise and Healthy Eating Programming as a Part of Supportive Adjuvant Care for Early Breast Cancer. Kirkham, AA., Van Patten, CL., Gelmon, KA., et al.[2019]

A case study of a breast cancer patient who underwent two mastectomies and subsequent treatments showed that a 6-month exercise intervention significantly improved her muscular strength and cardiovascular function.

The exercise program also helped reduce cancer-related fatigue and depression, highlighting the importance of collaborative health efforts to enhance the quality of life for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A case study: prescriptive exercise intervention after bilateral mastectomies. Carter, SD., Drum, SN., Hayward, R., et al.[2004]

A systematic review of eight studies involving 379 cancer patients found that fasting for short periods during chemotherapy does not improve quality of life or reduce side effects and toxicities associated with treatment.

The evidence suggests that fasting may lead to unintentional weight loss, which can negatively impact clinical outcomes, indicating that fasting is not recommended for cancer patients undergoing chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fasting during cancer treatment: a systematic review. Drexler, U., Dörfler, J., von Grundherr, J., et al.[2023]

Exercise and combined exercise and nutritional interventions are generally well-tolerated in patients with advanced or metastatic cancer, with few adverse effects reported.

These interventions can help preserve lean mass in cancer patients, and only the combined approach has shown potential to alter fat mass, indicating a need for more research to fully understand their benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Exercise and Nutritional Interventions on Body Composition in Patients with Advanced or Metastatic Cancer: A Systematic Review. Barnes, O., Wilson, RL., Gonzalo-Encabo, P., et al.[2022]

The NEXTAC program, which combines exercise and nutritional interventions, demonstrated excellent feasibility with 96.7% of elderly cancer patients attending at least four out of six sessions, indicating high compliance with the program.

The interventions were found to be safe, with only mild adverse events reported in a small number of patients, suggesting that this multimodal approach could be beneficial for elderly patients undergoing chemotherapy for advanced cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of early multimodal interventions for elderly patients with advanced pancreatic and non-small-cell lung cancer. Naito, T., Mitsunaga, S., Miura, S., et al.[2021]

Fasting combined with exercise may enhance cancer treatment outcomes by potentially protecting healthy cells while allowing chemotherapy to target cancer cells more effectively, although this combination has not been extensively studied in cancer patients.

While both fasting and exercise independently show benefits for cancer patients, including improved quality of life and reduced side effects from treatment, the safety and efficacy of their combined use in oncology remain uncertain and require further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fasting and Exercise in Oncology: Potential Synergism of Combined Interventions. Wilson, RL., Kang, DW., Christopher, CN., et al.[2021]

Citations

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Effectiveness of exercise modalities on breast cancer ... Overall exercise significantly improves the HRQOL, CRF and physical function in patients with BC. HRQOL was improved with all exercise types.

2. biosignaling.biomedcentral.com biosignaling.biomedcentral.com/articles/10.1186/s12964-024-01634-6

Outcomes of physical exercises on initiation, progression, and ... Evidence has suggested that participation in physical activity is correlated with a decrease in reappearance and fatality rates of breast cancer patients.

3. nature.com nature.com/articles/s41591-024-03143-y

Supervised, structured and individualized exercise in ... Our results indicate that the exercise intervention not only had a positive effect on physical fatigue and HRQOL but also on pain and dyspnea.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11806920/

Effect of low- and moderate-intensity endurance exercise on ... The most recent exercise guidelines for breast cancer survivors recommend participating in moderate-intensity exercise for at least 30 min, three times per week ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0031940624004322

Systematic review The effects of a prescribed exercise ... There is currently insufficient evidence to support the use of prescribed exercise to improve QOL, physical performance, muscle health, CRF and PA in PwMBC.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5775062/

Physical Activity and Survival in Women with Advanced ... Engaging in one additional hour per day of moderate activity reduced the hazard of subsequent mortality by 23% (HR=0.77, 95% CI=0.65, 0.92, p<.01). These ...

7. cancer.gov cancer.gov/news-events/cancer-currents-blog/2020/breast-cancer-survival-exercise

Exercise and Survival for Women with Breast Cancer - NCI A new study adds to existing evidence linking physical activity with longer survival in women diagnosed with high-risk breast cancer.