NCT06454864Recruiting
Multiple Risk Factor Intervention Trial in Breast Cancer Survivors
Source: ClinicalTrials.gov · Last updated 1 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- First submitted
- 22 May 2024
- Start date
- Jul 2024
- Primary completion date
- Oct 2026
- Lead sponsor
- University of Toronto
- Diseases
- Childhood cancers
- NCT number
- NCT06454864
What you commit to
- Study type: Interventional
- Planned participants: 45
- From Jul 2024 to the primary completion date, Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received chemotherapy within the past 11 months
- Currently taking tamoxifen
- Currently receiving chemotherapy, targeted therapy or radiation treatment
- Contraindications to research MRI (e.g., pacemaker, magnetic implants)
- Currently taking weight loss medications
Other illness
- Diagnosed with metastatic cancer
- 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)
- Diagnosed history of an eating disorder or self-report of potential undiagnosed eating disorder
- Allergies to local anesthetics
Other
- 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
- 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
- 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).
Who the study is looking for
- 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)
- 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.
Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Toronto Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.