Exercise + Plant-Based Diet for Breast Cancer

Recruiting in Palo Alto (17 mi)

+9 other locations

Overseen byNeil Iyengar, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this study is to find out what effects, if any, exercise and a plant-based diet have on aromatase levels in postmenopausal women who are overweight and being treated with an aromatase inhibitor for their HR+ breast cancer. The study will also look at other ways diet and exercise may affect your body (for example, changing the way your breast tissue expresses or makes genes) and your quality of life.

Eligibility Criteria

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

I am 18 years old or older.

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

I am postmenopausal.

See 10 more

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.

See 3 more

Treatment Details

Interventions

Exercise Treatment (Behavioural Intervention)
Nutrition counseling (Behavioural Intervention)
Physical activity (Behavioural Intervention)
Plant-Based Diet (Behavioural Intervention)
Replication Exercise Test (Behavioural Intervention)

Trial OverviewThe 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.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Exercise Treatment and Plant-Based DietExperimental Treatment3 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 counselingActive Control2 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.