A Study of the Body's Response to Exercise and a Plant-Based Diet in Overweight Postmenopausal Women With Breast Cancer

Study Overview
=================
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.

Official Title
-----------------
Pharmacodynamic Response to Exercise Treatment and Plant-Based Diet in Overweight/Obese Postmenopausal Women With Primary Hormone Receptor Positive Breast Cancer: A Phase 2 Randomized Control Trial

Conditions
-----------------
Breast Cancer, Primary Hormone Receptor Positive Breast Cancer

Intervention / Treatment
-----------------
* Other: Exercise Treatment
* Other: Plant-Based Diet
* Other: Physical activity
* Other: Nutrition counseling
* Other: Replication Exercise Test


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise Treatment and Plant-Based Diet<br>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 | Other: Exercise Treatment<br>* 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.<br>Other: Plant-Based Diet<br>* Pre-prepared meals, including 6 dinners and 6 lunches per week, will be shipped to the partipant's home during the intervention.<br>Other: Replication Exercise Test<br>* Exercise capacity will be reassessed by a replication exercise test at week 6 in the intervention group only.<br>|
| Active Comparator: Physical activity and nutrition counseling<br>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. | Other: Physical activity<br>* Treadmills and low-calorie recipes will be provided to patients in the counseling arm.<br>Other: Nutrition counseling<br>* Nutrition program including regular counseling by exercise physiologists and registered dieticians (RDs).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in breast aromatase levels | 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. | 24 weeks post-intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postmenopausal Women, Overweight/Obese, Plant-Based Diet, 19-486