Multiple Risk Factor Intervention Trial in Breast Cancer Survivors

NCT06454864 | Recruiting

• 1 other identifier: REB #45301
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Disturbance; Sedentary Behavior; Breast Cancer Female

Outcome Measures

Primary Outcomes (1)

• Insulin resistance

  As assessed by the Matsuda Index calculated from an oral glucose tolerance test (OGTT).

  6 months

Secondary Outcomes (3)

• Hepatic insulin resistance

  6 months

• Metabolic syndrome severity

  6 months

• Framingham 10-year risk (%)

  6 months

Other Outcomes (38)

• Cardiorespiratory fitness

  6 months

• Heart Rate Recovery

  6 months

• avO2 difference

  6 months

Study Arms (3)

Guidelines-based physical activity

EXPERIMENTAL

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

Behavioral: Guidelines-based physical activity

Guidelines-based physical activity and healthy eating

EXPERIMENTAL

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

Behavioral: Guidelines-based healthy eating; Behavioral: Guidelines-based physical activity

Stretching exercise

PLACEBO COMPARATOR

Whole-body stretching.

Behavioral: Stretching exercise

Interventions

Guidelines-based healthy eating BEHAVIORAL

One-on-one phone/virtual counselling from a registered dietitian to change dietary habits to be in line with Canada's Food Guide.

Guidelines-based physical activity and healthy eating

Guidelines-based physical activity BEHAVIORAL

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.

Guidelines-based physical activity; Guidelines-based physical activity and healthy eating

Stretching exercise BEHAVIORAL

Twice weekly virtual instructor-led whole-body stretching.

Stretching exercise

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 (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

Sponsors & Collaborators

• University of Toronto: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

University of Toronto

Toronto, Ontario, M5S 2C9, Canada

RECRUITING

MeSH Terms

Conditions

Sedentary Behavior

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Amy A Kirkham, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy A Kirkham, PhD

CONTACT

416-946-4069; amy.kirkham@utoronto.ca

Jenna B Gillen, PhD

CONTACT

416-978-3244; jenna.gillen@mail.utoronto.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 3-arm parallel-group randomized controlled trial

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: June 12, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)