A Study of the Body's Response to Exercise and a Plant-Based Diet in Overweight Postmenopausal Women With Breast Cancer
Keywords
Abstract
Dates
| Last Verified: | 03/31/2020 |
| First Submitted: | 03/03/2020 |
| Estimated Enrollment Submitted: | 03/03/2020 |
| First Posted: | 03/05/2020 |
| Last Update Submitted: | 04/01/2020 |
| Last Update Posted: | 04/05/2020 |
| Actual Study Start Date: | 03/03/2020 |
| Estimated Primary Completion Date: | 02/28/2022 |
| Estimated Study Completion Date: | 02/28/2022 |
Condition or disease
Intervention/treatment
Other: Exercise Treatment and Plant-Based Diet
Other: Exercise Treatment and Plant-Based Diet
Other: Physical activity and nutrition counseling
Other: Physical activity and nutrition counseling
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: Exercise Treatment and Plant-Based Diet 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 at MSK or 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. | Other: Exercise Treatment and 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 at MSK or under remote surveillance using a telemedicine approach (i.e.,TeleEx) established in the Exercise-Oncology (ExOnc) Service. |
| Active Comparator: Physical activity and nutrition counseling Will consist of a general physical activity and nutrition program including regular counseling by exercise physiologists and registered dieticians. Treadmills and low-calorie recipes will be provided to patients in the counseling arm. | Other: Physical activity and nutrition counseling Treadmills and low-calorie recipes will be provided to patients in the counseling arm. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | Female |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - Patients with histologically-confirmed, HR-positive (ER and/or PR), HER2-negative stage 1-3 breast cancer - 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., <150 minutes / week of exercise) - 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 - Insulin-dependent diabetes mellitus or non-insulin dependent diabetes mellitus on medical therapy - Enrollment onto any other therapeutic investigational study - Mental impairment leading to inability to cooperate - Any of the following contraindications to exercise: 1. Acute myocardial infarction within 3-5 days of any planned study procedures; 2. Unstable angina 3. Uncontrolled arrhythmia causing symptoms or hemodynamic compromise 4. Recurrent syncope 5. Active endocarditis 6. Acute myocarditis or pericarditis 7. Symptomatic severe aortic stenosis 8. Uncontrolled heart failure 9. Acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures 10. Thrombosis of lower extremities 11. Suspected dissecting aneurysm 12. Uncontrolled asthma 13. Pulmonary edema 14. Respiratory failure 15. 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 or other exercise programs |
Outcome
Primary Outcome Measures
1. change in breast aromatase levels [24 weeks post-intervention]
