Actively Recruiting
Multiple Risk Factor Intervention Trial in Breast Cancer Survivors
Led by University of Toronto · Updated on 2025-10-01
45
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
Sponsors
U
University of Toronto
Lead Sponsor
C
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Multiple Risk Factor Intervention Trial in Breast Cancer Survivors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Biologically female
- Diagnosis of stage I, II, or III breast cancer, post-menopausal at the time of diagnosis (no menstrual cycle within 12 months or greater)
- Received aromatase inhibitors for 12 months or more in the past (current use not required)
- Willing and able to complete all study assessments
- Body Mass Index (BMI) of 25 kg/m2 or higher
- Able to attend the University once per week for 24 weeks
You will not qualify if you...
- Received chemotherapy within the past 11 months
- 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 such as COPD or severe/uncontrolled asthma
- Major signs or symptoms of cardiovascular diseases, diabetes, or renal disease including chest pain, shortness of breath, dizziness, loss of balance, ankle swelling, palpitations, intermittent claudication, heart murmur, or unusual fatigue
- Absolute or relative contraindications for maximal exercise testing per American Heart Association guidelines including myocardial infarction, heart block, stroke, high blood pressure, and others
- Unable to provide informed consent or communicate in English
- Pregnant or breast-feeding currently or in the past 3 months
- Mobility limitations impacting aerobic exercise (e.g., wheelchair, walker use, limp)
- Smoking cigarettes or marijuana within the past 3 months
- Taking exogenous hormones currently or in the past 3 months
- Contraindications to research MRI such as pacemaker or magnetic implants
- Body Mass Index (BMI) over 40 kg/m2
- Extreme claustrophobia
- More than 30 minutes per week of moderate-to-vigorous aerobic physical activity
- Following a diet that restricts entire food groups or limits eating times (e.g., vegan, ketogenic, carnivore, one meal a day) in the last 3 months
- Significant weight loss over 5 kg in the past 3 months
- Currently taking weight loss medications
- Diagnosed or suspected eating disorder
- Plans to be away or unavailable for more than 4 weeks during the 6-month intervention or more than 2 weeks in the first 12 weeks
- Allergies to local anesthetics
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Toronto
Toronto, Ontario, Canada, M5S 2C9
Actively Recruiting
Research Team
A
Amy A Kirkham, PhD
CONTACT
J
Jenna B Gillen, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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