Breast Cancer, Primary Hormone Receptor Positive Breast Cancer
Conditions
Keywords
Postmenopausal Women, Overweight/Obese, Plant-Based Diet, 19-486
Brief summary
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.
Interventions
OTHERExercise Treatment
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 under remote surveillance using a telemedicine approach (i.e.,TeleEx) established in the Exercise-Oncology (ExOnc) Service.
OTHERPlant-Based Diet
Pre-prepared meals, including 6 dinners and 6 lunches per week, will be shipped to the partipant's home during the intervention.
OTHERPhysical activity
Treadmills and low-calorie recipes will be provided to patients in the counseling arm.
OTHERNutrition counseling
Nutrition program including regular counseling by exercise physiologists and registered dieticians (RDs).
OTHERReplication Exercise Test
Exercise capacity will be reassessed by a replication exercise test at week 6 in the intervention group only.
Sponsors
Memorial Sloan Kettering Cancer Center
American Cancer Society, Inc.
McGill University
University of Kansas Medical Center
Wake Forest University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A single-center, phase 2 randomized control trial of structured exercise treatment and plant-based diet versus physical activity and nutrition counseling for 24 weeks.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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: 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 programs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in breast aromatase levels | 24 weeks post-intervention | Will explore the data using descriptive statistics and graphical methods, such as summarizing the aromatase levels at baseline and at 24 weeks using means and medians and plotting the data to visualize changes over time. To compare the aromatase levels at 24 weeks post-intervention between the groups, an analysis of covariance (ANCOVA) model will be used. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJessica Scott, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed