Multiple Risk Factor Intervention Trial in Breast Cancer Survivors

Launched by UNIVERSITY OF TORONTO · Jun 6, 2024

Keywords

ClinConnect Summary

The Multiple Risk Factor Intervention Trial in Breast Cancer Survivors is a study looking at how exercise and diet can help women who have survived breast cancer improve their heart and metabolic health. The trial will involve three groups of participants: one group will follow the recommended exercise guidelines, the second group will do the same exercise but also receive dietary counseling to improve their eating habits, and the third group will participate in stretching exercises. The study aims to find out how exercise affects health and body composition, whether adding dietary advice makes a difference, and how well the participants' muscles respond to exercise and diet in relation to insulin resistance, which is a key factor in diabetes.

To be eligible for this study, participants must be biologically female, diagnosed with early-stage breast cancer (stages I, II, or III), and have completed chemotherapy between 1 to 10 years ago. They should also be post-menopausal and have a body mass index (BMI) of 25 or higher. Participants will need to commit to attending weekly sessions at the university for six months. It's important to note that certain health conditions, current treatments, or medications may exclude individuals from participating. This study is a great opportunity for breast cancer survivors to engage in a program that could potentially enhance their overall health and well-being.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Biologically female
• • Diagnosis of stage I, II, or III breast cancer, post-menopausal at the time of diagnosis (haven't had a menstrual cycle within 12 months or greater) Received chemotherapy and completed it at least 1 and up to 10 years prior
• • Receipt of aromatase inhibitors for 12 months or more in the past, but do not have to be currently on aromatase inhibitors.
• • Willing and able to complete all study assessments
• • BMI ≥ 25 kg/m2
• • Able to commit to come to the University once per week for 24 weeks.
• Exclusion Criteria:
• • Diagnosed with metastatic cancer
• • Currently taking tamoxifen
• • Currently receiving chemotherapy, targeted therapy or radiation treatment
• • Distant recurrence or diagnosis of metastatic cancer since early-stage breast cancer diagnosis
• • Diagnosed cardiovascular diseases, type 2 diabetes, non-alcoholic fatty liver disease, uncontrolled thyroid condition, or respiratory disease (e.g., COPD or severe or uncontrolled asthma).
• • Major signs or symptoms of cardiovascular diseases, diabetes, or renal disease (taken from the American College of Sports Medicine's Guidelines for Exercise Testing and Prescription 11th edition Table 2.1: pain or discomfort in the chest, neck, jaw, arms with rest or exercise, shortness of breath at rest or with mild exertion, dizziness or syncope, loss of balance or passing out, ankle edema, palpitations or tachycardia, intermittent claudication, known heart murmur, unusual fatigue with usual activities.)
• • American Heart Association's absolute or relative contraindications for symptom-limited maximal exercise testing (myocardial infarction, aortic or coronary artery stenosis, heart failure, pulmonary embolism or deep vein thrombosis, inflammation of the heart (myocarditis, pericarditis, and/or endocarditis), uncontrolled cardiac arrhythmia, advanced or complete electrical heart block, stroke or transient ischemia attack, blood pressure \>200mmHg/100mmHg, a cancer diagnosis other than skin cancer)
• • Unable to provide informed consent or communicate in English
• • Pregnant or breast-feeding currently or in the past 3 months
• • Mobility limitations to aerobic exercise (i.e., wheelchair, walker use, limp impeding walking)
• • Smoking cigarettes or marijuana within the past 3 months
• • Taking exogenous hormones in any format currently or in the past 3 months
• • Contraindications to research MRI (e.g., pacemaker, magnetic implants)
• • BMI exceeding 40 kg/m2
• • Extreme claustrophobia
• • Self-report \>30 min/week of moderate-to-vigorous intensity aerobic physical activity
• • Following a diet that largely restricts entire food groups or time of eating (e.g., vegan, ketogenic, carnivore, one meal a day) in last 3 months
• • Experienced significant weight loss (i.e., \>5 kg) in past 3 months
• • Currently taking weight loss medications
• • Diagnosed history of an eating disorder or self-report of potential undiagnosed eating disorder
• • Plans to be away/unavailable for a substantial period of the intervention overall (i.e., \>4 weeks throughout the 6 months or \>2 weeks within the first 12 weeks of the intervention).
• • Allergies to local anesthetics