This phase II trial studies the effects of exercise and a plant-based diet on breast aromatase levels in patients with hormone receptor positive stage I-III breast cancer. Aromatase is an enzyme that impacts the amount of estrogen in the body. High aromatase levels can increase estrogen levels and cause tumor growth. A plant-based diet consists of fruits, vegetables, whole grains, legumes, nuts and seeds, herbs, and spices and does not include any animal products, such as red meat, poultry, fish, eggs, and dairy products. Exercise combined with a plant-based diet may help slow the growth of cancer by decreasing aromatase levels, promoting other positive changes in the body, and causing weight loss. The purpose of this study is to find out what effects, if any, exercise and a plant-based diet may have on aromatase levels in postmenopausal women who are overweight and being treated with an aromatase inhibitor for their hormone positive breast cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04298086.
PRIMARY OBJECTIVE:
I. To determine the effect of the exercise and diet intervention on breast aromatase levels.
SECONDARY OBJECTIVES:
I. To examine the effects of the exercise and diet intervention on gene expression in breast tissue.
II. To examine the effects of the exercise and diet intervention on circulating metabolic and proinflammatory growth factors.
III. To describe the effects of the exercise and diet intervention on physiological correlates (e.g., exercise capacity, body weight, body composition, blood pressure).
IV. To evaluate the effects of the exercise and diet intervention on quality of life (QOL) and patient reported outcome (PRO) measures.
V. To explore the effects of the exercise and diet intervention on gut microbiome diversity.
VI. To assess patient-initiated dietary and exercise changes.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients complete individualized walking sessions at home up to 7 times weekly over 10-75 minutes monitored by an exercise physiologist and receive a temporary unsupervised training program for 6 months. Patients also receive plant-based pre-prepared meal delivery. Patients also undergo blood sample collection throughout the trial.
ARM II: Patients complete home-based aerobic walking program with a goal of walking up to 150 minutes weekly for 6 months. Patients also receive nutrition education and/or counseling and low-calorie recipes. Patients also undergo blood sample collection throughout the trial.
After completion of study treatment, patients are followed up within 2 weeks.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorJessica Scott