Multiple Risk Factor Intervention Trial in Breast Cancer Survivors

Trial Title: Multiple Risk Factor Intervention Trial in Breast Cancer Survivors

NCT ID: NCT06454864

Condition: Metabolic Disturbance
Sedentary Behavior
Breast Cancer Female

Conditions: Official terms:
Breast Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: 3-arm parallel-group randomized controlled trial

Primary purpose: Prevention

Masking: Single (Outcomes Assessor)

Masking description: It is not possible to blind participants to their assigned intervention. Care providers are not involved. The outcome assessors for any assessments involving potential for subjectivity in data collection or analysis will be blinded to group assignment.

Intervention:

Intervention type: Behavioral
Intervention name: Guidelines-based healthy eating
Description: One-on-one phone/virtual counselling from a registered dietitian to change dietary habits to be in line with Canada's Food Guide.
Arm group label: Guidelines-based physical activity and healthy eating

Intervention type: Behavioral
Intervention name: Guidelines-based physical activity
Description: Through a combination of exercise trainer-led in-person and virtual sessions, as well as counselling for independent aerobic exercise, participants will be guided to achieve 150 weekly minutes of moderate-intensity aerobic activity and twice weekly whole-body muscle strengthening.
Arm group label: Guidelines-based physical activity
Arm group label: Guidelines-based physical activity and healthy eating

Intervention type: Behavioral
Intervention name: Stretching exercise
Description: Twice weekly virtual instructor-led whole-body stretching.
Arm group label: Stretching exercise

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.

Criteria for 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

Gender: Female

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University of Toronto

Address:
City: Toronto
Zip: M5S 2C9
Country: Canada

Start date: August 8, 2024

Completion date: June 1, 2028

Lead sponsor:
Agency: University of Toronto
Agency class: Other

Collaborator:
Agency: Canadian Institutes of Health Research (CIHR)
Agency class: Other

Source: University of Toronto

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06454864