Multiple Risk Factor Intervention Trial in Breast Cancer Survivors

Not Applicable

Not yet recruiting

• Conditions: Sedentary Behavior; Breast Cancer Female; Metabolic Disturbance
• Interventions: Behavioral: Guidelines-based healthy eating; Behavioral: Stretching exercise; Behavioral: Guidelines-based physical activity

• Registration Number: NCT06454864
• Lead Sponsor: University of Toronto

Brief Summary

This study aims to produce new evidence on the efficacy of exercise and diet for cardiometabolic risk reduction in BC survivors. Using a 3-arm RCT with to 6 months of 1) exercise following Health Canada guidelines; 2) the same exercise plus counselling to follow Canada's Dietary Guidelines to improve diet quality; or 3) stretching group, this study will answer the following questions:

* What is the impact of exercise on cardiometabolic health and body composition in BC survivors?

* What is the effect modification of adding a diet quality intervention to exercise on cardiometabolic health and body composition?

* Is there a link between the capacity of skeletal muscle adaptation to exercise (and diet) and insulin resistance in BC survivors?

The investigators hypothesize that: 1) exercise will improve cardiometabolic and body composition outcomes 2) improvements in cardiometabolic outcomes will be enhanced by the addition of diet quality, which will be essential or additive for Matsuda index, metabolic syndrome, Framingham CVD risk, thigh myosteatosis, muscle mass, VO2peak, 3) skeletal muscle insulin signalling transduction will be impaired in BC survivors via dampened expression of insulin-responsive proteins (e.g. GLUT4) and co-occur with impaired muscle quality (e.g., higher rates of fat depots, presence of fibrous tissue) negatively impacting insulin signalling.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-22
• Study First Submitted QC: 2024-06-06
• Study First Posted: 2024-06-12
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-05
• Study Start: 2024-08-08
• Primary Completion: 2027-06-01
• Study Completion: 2028-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Guidelines-based physical activity and healthy eating	Guidelines-based healthy eating	Arm Description: 150 weekly minutes of moderate-intensity aerobic activity and twice weekly whole-body muscle strengthening + counselling to follow Canada's Food Guide.
Stretching exercise	Stretching exercise	Whole-body stretching.
Guidelines-based physical activity	Guidelines-based physical activity	150 weekly minutes of moderate-intensity aerobic activity and twice weekly whole-body muscle strengthening.
Guidelines-based physical activity and healthy eating	Guidelines-based physical activity	Arm Description: 150 weekly minutes of moderate-intensity aerobic activity and twice weekly whole-body muscle strengthening + counselling to follow Canada's Food Guide.

Primary Outcome Measures

Name	Time	Method
Insulin resistance	6 months	As assessed by the Matsuda Index calculated from an oral glucose tolerance test (OGTT).

Secondary Outcome Measures

Name	Time	Method
Framingham 10-year risk (%)	6 months	Calculated using a widely-used standardized scoring system
Hepatic insulin resistance	6 months	Indirectly measured via HOMA-IR using fasting glucose and insulin levels
Metabolic syndrome severity	6 months	Calculated as a z-score to allow for tracking change in the interventions

Trial Locations

Locations (1)

University of Toronto; 🇨🇦 Toronto, Ontario, Canada