Multiple Risk Factor Intervention Trial in Breast Cancer Survivors

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorUniversity of Toronto

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Received chemotherapy within the past 11 months

Diagnosed with metastatic cancer

Currently taking tamoxifen

Currently receiving chemotherapy, targeted therapy or radiation treatment

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

    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.

  • Stretching exercise

    Behavioral

    Twice weekly virtual instructor-led whole-body stretching.

Treatment groups

45 Participants
are divided into 3 treatment groups
Group A: Guidelines-based physical activityExperimental treatment 1 intervention
Group B: Guidelines-based physical activity and healthy eatingExperimental treatment 2 interventions
Group C: Stretching exercisePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Insulin resistance

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

Time frame
6 months

Secondary outcomes

1

Hepatic insulin resistance

Indirectly measured via HOMA-IR using fasting glucose and insulin levels

Time frame
6 months
2

Metabolic syndrome severity

Calculated as a z-score to allow for tracking change in the interventions

Time frame
6 months
3

Framingham 10-year risk (%)

Calculated using a widely-used standardized scoring system

Time frame
6 months

Other outcomes

1

Cardiorespiratory fitness

Measured as peak volume of oxygen consumption via indirect calorimetry during a cardiopulmonary exercise test on a treadmill.

Time frame
6 months
2

Heart Rate Recovery

Measured as the difference between peak heart rate during the cardiorespiratory fitness test and heart rate 2-minutes after stopping the exercise test.

Time frame
6 months
3

avO2 difference

Calculated as the VO2 from the corresponding workload from the day 1 treadmill test divided by cardiac output at rest, submaximal, and maximal periods of the treadmill test

Time frame
6 months
4

Blood Pressure

Measured as the average of the last 5 of 6 blood pressure measurements using an automatic blood pressure device.

Time frame
6 months

Sponsors and contacts

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University of Toronto

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator