A Study of the Body's Response to Exercise and a Plant-Based Diet in Overweight Postmenopausal Women With Breast Cancer
Breast Cancer, Primary Hormone Receptor Positive Breast Cancer
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Postmenopausal Women, Overweight/Obese, Plant-Based Diet, 19-486
Eligibility Criteria
Inclusion Criteria:
- Patients with histologically-confirmed, HR-positive (ER and/or PR) stage 1-3 breast cancer
- Completed anti-HER2 therapy, if HER2-positive
- Postmenopausal status defined by lack of menses for 2 years, oophorectomy, or medical ovarian suppression
- At least 3 months post completion of chemotherapy, if administered
- At least 3 months post radiation, if administered
- Receiving adjuvant endocrine therapy with an aromatase inhibitor (anastrozole, letrozole, exemestane)
- ECOG performance status of 0 to 1
- Sedentary (i.e.,performing <150 minutes / week of exercise structured moderate-intensity or strenuous-intensity)
- Age ≥ 18
- BMI ≥ 27
Able to achieve an acceptable peak baseline CPET, as defined by any of the following criteria and in the absence of high risk ECG findings or other inappropriate response to exercise as determined by the investigator:
- Achieved a plateau in oxygen consumption, concurrent with an increase in power output
- A respiratory exchange ratio ≥ 1.10
- Attainment of maximal predicted heart rate (HRmax) (i.e., within10 bpm of age- predicted HRmax [HRmax= 220 - Age (years)]
- Volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18 on the BORG scale.
- Willingness to comply with all study-related procedures
- Intact breast available for biopsy
Exclusion Criteria:
- Presence of metastatic disease
- Any concurrent malignancy requiring active treatment with the exception of selective estrogen receptor modulators and aromatase inhibitors
- Insulin-dependent diabetes mellitus or non-insulin dependent diabetes mellitus on insulin therapy
- Enrollment onto any other interventional investigational study except interventions determined by the PI not to confound the effect of exercise or diet on study outcomes
- Mental impairment leading to inability to cooperate
Any of the following contraindications to exercise:
- Acute myocardial infarction within 3-5 days of any planned study procedures;
- Unstable angina
- Uncontrolled arrhythmia causing symptoms or hemodynamic compromise
- Recurrent syncope
- Active endocarditis
- Acute myocarditis or pericarditis
- Symptomatic severe aortic stenosis
- Uncontrolled heart failure
- Acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures
- Thrombosis of lower extremities
- Suspected dissecting aneurysm
- Uncontrolled asthma
- Pulmonary edema
- Respiratory failure
- Acute non-cardiopulmonary disorders that may affect exercise performance
- Any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation.
- Nut or legume allergy
- Concurrent participation in weight loss programs
Sites / Locations
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
- Memorial Sloan Kettering Bergen (Limited Protocol Activities)
- Memorial Sloan Kettering Commack (Limited Protocol Activities)
- Memorial Sloan Kettering Westchester (Limited Protocol Activities)
- Memorial Sloan Kettering Cancer Center
- Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Exercise Treatment and Plant-Based Diet
Physical activity and nutrition counseling
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
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.