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Tests exercise and healthy eating for heart and diabetes risk in breast cancer survivors

Tests exercise, with or without diet advice, in breast cancer survivors with metabolic risk.

Key facts

Who runs it
University of Toronto
Where
Toronto, CanadaSee the site
Trial code
Registry title
Multiple Risk Factor Intervention Trial in Breast Cancer Survivors
Status
Recruiting
People taking part
45 people, planned
Started
1 Jul 2024
Expected to end
1 Apr 2027
Type of study
Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Guidelines-based healthy eating
  • Guidelines-based physical activity
  • Stretching exercise
Record updated
1 October 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for women who have had stage I, II or III breast cancer, were past menopause at diagnosis, and are now carrying extra weight. It tests exercise, with or without diet counselling.

Sex
Female only.
Disease stage
Stage I, II or III breast cancer, with menopause already passed at the time of diagnosis (no period for 12 months or more).
Earlier treatment
Must have taken aromatase inhibitors for 12 months or more in the past; they do not have to be taking them now. Must not have had chemotherapy in the past 11 months, and must not be taking tamoxifen now.

Main reasons for not taking part

  • Metastatic cancer, or cancer that has come back at a distant site
  • Heart disease, type 2 diabetes, fatty liver disease, uncontrolled thyroid condition or lung disease
  • BMI over 40 kg/m2, or BMI under 25 kg/m2
  • Pregnant or breast-feeding now or in the past 3 months
  • Already doing more than 30 min/week of moderate-to-vigorous aerobic activity

The registry criteria, word for word

Show all 29 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • 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
  • 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)

Where in Canada

  • University of TorontoToronto, CanadaContact: Amy A. Kirkham, PhDTaking people

About the trial

What the trial wants to find out

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:

Read full original descriptionShow less

* 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.

The 3 groups in the trial

  • Guidelines-based physical activityTreatment being tested

    150 weekly minutes of moderate-intensity aerobic activity and twice weekly whole-body muscle strengthening.

  • Guidelines-based physical activity and healthy eatingTreatment being tested

    Arm Description: 150 weekly minutes of moderate-intensity aerobic activity and twice weekly whole-body muscle strengthening + counselling to follow Canada's Food Guide.

    Treatment: Guidelines-based healthy eating and Guidelines-based physical activity

  • Stretching exercisePlacebo, for comparison

    Whole-body stretching.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Multiple Risk Factor Intervention Trial In Breast Cancer Survivors
Plain-language title
Tests exercise and healthy eating for heart and diabetes risk in breast cancer survivorsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
1 October 2025