RecruitingNot ApplicableNCT06454864

Multiple Risk Factor Intervention Trial in Breast Cancer Survivors

Multiple Risk Factor Intervention Trial In Breast Cancer Survivors


Sponsor

University of Toronto

Enrollment

45 participants

Start Date

Jul 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALE

Plain Language Summary

Simplified for easier understanding

This trial tests a lifestyle program targeting multiple risk factors — such as excess weight, physical inactivity, and metabolic health — in post-menopausal breast cancer survivors who previously took aromatase inhibitors (hormone-blocking drugs). The goal is to improve long-term health and reduce cancer recurrence risk. **You may be eligible if...** - You are biologically female with a history of stage I, II, or III breast cancer - You were post-menopausal at the time of diagnosis - You took aromatase inhibitors for at least 12 months (you do not need to be currently taking them) - Your BMI is 25 or above (overweight or obese) - You can attend the University once per week for 24 weeks **You may NOT be eligible if...** - You received chemotherapy in the past 11 months - You have metastatic or recurrent cancer - You have cardiovascular disease, type 2 diabetes, severe respiratory disease, or uncontrolled thyroid disease - You are currently on tamoxifen Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALGuidelines-based healthy eating

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

BEHAVIORALGuidelines-based physical activity

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.

BEHAVIORALStretching exercise

Twice weekly virtual instructor-led whole-body stretching.


Locations(1)

University of Toronto

Toronto, Ontario, Canada

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NCT06454864


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