Multiple Risk Factor Intervention Trial In Breast Cancer Survivors

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
University of Toronto
RECRUITING
Toronto
Contact Information
Primary
Amy A Kirkham, PhD
amy.kirkham@utoronto.ca
416-946-4069
Backup
Jenna B Gillen, PhD
jenna.gillen@mail.utoronto.ca
416-978-3244
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2027-04-01
Participants
Target number of participants: 45
Treatments
Experimental: Guidelines-based physical activity
150 weekly minutes of moderate-intensity aerobic activity and twice weekly whole-body muscle strengthening.
Experimental: Guidelines-based physical activity and healthy eating
Arm Description: 150 weekly minutes of moderate-intensity aerobic activity and twice weekly whole-body muscle strengthening + counselling to follow Canada's Food Guide.
Placebo_comparator: Stretching exercise
Whole-body stretching.
Related Therapeutic Areas
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR)
Leads: University of Toronto

This content was sourced from clinicaltrials.gov