Exercise + Plant-Based Diet for Breast Cancer

Not currently recruiting at 9 trial locations

Overseen By Lee Jones, PhD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must be taking: Aromatase inhibitors

Disqualifiers: Metastatic disease, Diabetes, Heart failure, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess the effects of exercise and a plant-based diet on hormone levels and overall well-being in postmenopausal women with HR-positive breast cancer who are overweight. Participants will either engage in a structured walking program with meal deliveries or receive guidance for home-based physical activity and nutrition. The trial suits women who are postmenopausal, have HR-positive breast cancer, are taking aromatase inhibitors, and lead a mostly inactive lifestyle. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important findings.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require that you continue taking an aromatase inhibitor for your breast cancer treatment.

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

Research shows that exercise and a plant-based diet are generally safe for people with breast cancer. Studies have found that women who combined exercise with a plant-based diet lost weight and improved their heart and overall health. This suggests the approach is safe and manageable. Additionally, physical activity is linked to a lower risk of dying from any cause for those with breast cancer. While eating a diet rich in vegetables and fruits might help prevent cancer, the evidence remains mixed. Overall, this method appears safe for use in breast cancer treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this trial because it explores a unique combination of exercise and a plant-based diet to potentially improve outcomes for breast cancer patients. Unlike traditional treatments that often focus on medication and surgery, this approach emphasizes a lifestyle change with structured, individualized exercise and a calorie-restricted plant-based diet. The use of telemedicine to deliver these exercise sessions and the convenience of pre-prepared meal deliveries make this method innovative and accessible. By incorporating technology and dietary changes, researchers hope to uncover new ways to support breast cancer treatment through non-invasive, sustainable methods.

What evidence suggests that this trial's treatments could be effective for breast cancer?

This trial will compare two approaches: an Exercise Treatment and Plant-Based Diet, and a Physical Activity and Nutrition Counseling program. Research has shown that exercise and a plant-based diet can benefit women with breast cancer. Studies have found that women who exercise regularly and eat mostly plants tend to lose weight, which is linked to lower death rates from breast cancer. Additionally, increased activity and healthier eating can lead to better outcomes, such as adherence to chemotherapy treatments and fewer side effects. Overall, exercise and a healthy diet appear to positively affect breast cancer treatment. ^{1 5 6 7 8}

Who Is on the Research Team?

Jessica Scott, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for overweight postmenopausal women with hormone receptor-positive breast cancer stages 1-3, who are sedentary and currently treated with an aromatase inhibitor. Participants must be willing to follow the study procedures, have completed any anti-HER2 or chemotherapy treatments at least 3 months prior, and not have any other active cancers or conditions that would limit their ability to exercise.

Inclusion Criteria

My breast cancer is in stages 1-3 and hormone receptor positive.

I am postmenopausal.

You do not exercise for at least 150 minutes per week at a moderate or high intensity.

Exclusion Criteria

I am not part of any other clinical trials that affect this study's results, except those approved by the study leader.

I am mentally capable of following study procedures.

My cancer has spread to other parts of my body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo structured exercise treatment and a calorie-restricted plant-based diet, with individualized walking and pre-prepared meals delivered to their homes.

24 weeks

Remote surveillance using telemedicine

Follow-up

Participants are monitored for changes in breast aromatase levels and other health outcomes post-intervention.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exercise Treatment
• Nutrition counseling
• Physical activity
• Plant-Based Diet
• Replication Exercise Test

Trial Overview The study investigates how a combination of exercise treatment and a plant-based diet affects aromatase levels in participants. It also examines changes in gene expression within breast tissue and overall quality of life improvements due to these interventions.

How Is the Trial Designed?

Group I: Exercise Treatment and Plant-Based Diet Experimental Treatment 3 Interventions

Will consist of structured exercise treatment plus a calorie-restricted plant-based diet. Exercise treatment will consist of individualized walking delivered up to 7 times weekly to achieve the patient-specific goal energy expenditure. Training sessions will be performed on a treadmill under remote surveillance using a telemedicine approach (i.e.,TeleEx) established in the Exercise-Oncology (ExOnc) Service. Pre-prepared meals, including 6 dinners and 6 lunches per week, will be shipped to the partipant's home during the intervention. If a patient is temporarily unable to complete supervised sessions as a result of unforeseen circumstances, patients may be assigned low intensity unsupervised training sessions per EP/PI discretion

Group II: Physical activity and nutrition counseling Active Control 2 Interventions

Patients will receive a home-based, general physical activity program and nutrition counseling. Specifically, all patients assigned to the counseling arm will receive a study kit which includes an activity tracker, heart rate monitor, scale, and tablet. Treadmills may also be provided to patients in the counseling arm if they do not already have access to one.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Wake Forest University

Collaborator

Trials

193

Recruited

151,000+

McGill University

Collaborator

Trials

421

Recruited

1,017,000+

University of Kansas Medical Center

Collaborator

Trials

527

Recruited

181,000+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

Published Research Related to This Trial

The simultaneous stage-matched exercise and diet (SSED) intervention was found to be feasible and well-accepted among 45 breast cancer survivors, with 91% completing the trial and 100% receiving intervention calls.

Participants in the SSED group showed significant improvements in motivational readiness for exercise and diet, as well as better emotional functioning, reduced fatigue, and lower depression compared to the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized pilot test of a simultaneous stage-matched exercise and diet intervention for breast cancer survivors. Kim, SH., Shin, MS., Lee, HS., et al.[2022]

In an 8-week pilot study involving 10 sedentary, overweight breast cancer patients, participants showed significant improvements in body composition, including an average weight loss of 2.6 pounds and reductions in waist and hip circumference.

The intervention, which included thrice-weekly monitored aerobic exercise and a low-fat diet, demonstrated that breast cancer patients are motivated to adhere to such programs, leading to positive changes in health metrics despite only slight changes in hormone levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anthropometric and hormone effects of an eight-week exercise-diet intervention in breast cancer patients: results of a pilot study. McTiernan, A., Ulrich, C., Kumai, C., et al.[2007]

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]

Increased caloric intake and body weight are linked to a higher risk of various cancers, with total caloric intake being more critical than dietary fat percentage in tumor development, as shown in both animal and human studies.

Omega-3 fatty acids and regular exercise have protective effects against cancer, with exercise not only reducing tumor formation but also improving overall mortality rates and lowering cancer risk in specific populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional cancer risks derived from energy and fat. Simopoulos, AP.[2019]

The motivational-volitional program (MoVo-BnB) significantly increased physical activity levels in breast cancer patients, with the intervention group exercising an average of 22 minutes more per week than the control group at the 12-month follow-up.

Nearly half (49.1%) of the intervention group achieved the recommended 60 minutes of exercise per week, compared to only 37.6% in the control group, indicating the program's effectiveness in promoting long-term physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A Motivational-Volitional Program for Women after Breast Cancer Increases Physical Activity 12 Months Post Rehabilitation - Results of a Prospective Controlled Trial]. Adams, L., Feicke, J., Eckert, T., et al.[2022]

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]

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