Metabolic DisturbanceMsFITBCNCT06454864
Multiple Risk Factor Intervention Trial in Breast Cancer Survivors
A study testing Guidelines-based healthy eating, Guidelines-based physical activity and Stretching exercise in people with Metabolic Disturbance and Sedentary Behavior, run by University of Toronto at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Metabolic Disturbance, Sedentary Behavior, Breast Cancer Female
- What is being tested?
- Guidelines-based healthy eating, Guidelines-based physical activity and Stretching exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2024to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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 join
- 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).
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- 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
- 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
- Currently taking weight loss medications
- Diagnosed history of an eating disorder or self-report of potential undiagnosed eating disorder
- 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).
- Allergies to local anesthetics
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Toronto
Toronto, Ontario, M5S 2C9
Amy A. Kirkham, PhD, 416-946-4069, amy.kirkham@utoronto.ca
Jenna B. Gillen, PhD, 416-978-3244, jenna.gillen@utoronto.ca
About this study
Official title: Multiple Risk Factor Intervention Trial In Breast Cancer Survivors
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.
- Being tested
- Guidelines-based healthy eating, Guidelines-based physical activity, Stretching exercise
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guidelines-based healthy eatingBehavioural
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 activityBehavioural
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 exerciseBehavioural
Twice weekly virtual instructor-led whole-body stretching.
| Study group | Role | What they receive |
|---|---|---|
| Guidelines-based physical activity | Experimental | 150 weekly minutes of moderate-intensity aerobic activity and twice weekly whole-body muscle strengthening. Receives: 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. Receives: Behavioral: Guidelines-based healthy eating; Behavioral: Guidelines-based physical activity |
| Stretching exercise | Placebo comparator | Whole-body stretching. Receives: Behavioral: Stretching exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin resistance
As assessed by the Matsuda Index calculated from an oral glucose tolerance test (OGTT).
Measured: 6 months
Secondary outcomes (3)
Hepatic insulin resistance
Indirectly measured via HOMA-IR using fasting glucose and insulin levels
Measured: 6 months
Metabolic syndrome severity
Calculated as a z-score to allow for tracking change in the interventions
Measured: 6 months
Framingham 10-year risk (%)
Calculated using a widely-used standardized scoring system
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start1 Jul 2024
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DisturbanceStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3-arm parallel-group randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Amy Kirkham, University of Toronto
- Investigators
- Amy A Kirkham, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06454864
- Sponsor's protocol ID
- REB #45301
- Acronym
- MsFITBC
- Status last verified
- Sep 2025
- First submitted
- 22 May 2024
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Risk Factor Intervention Trial In Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT06454864
- Acronym / sponsor ID
- MsFITBC / REB #45301
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 12 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 3-arm parallel-group randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Guidelines-based physical activity | Experimental | Behavioral: Guidelines-based physical activity150 weekly minutes of moderate-intensity aerobic activity and twice weekly whole-body muscle strengthening. |
| Guidelines-based physical activity and healthy eating | Experimental | Behavioral: Guidelines-based healthy eating, Behavioral: Guidelines-based physical activityArm Description: 150 weekly minutes of moderate-intensity aerobic activity and twice weekly whole-body muscle strengthening + counselling to follow Canada's Food Guide. |
| Stretching exercise | Placebo comparator | Behavioral: Stretching exerciseWhole-body stretching. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guidelines-based healthy eatingOne-on-one phone/virtual counselling from a registered dietitian to change dietary habits to be in line with Canada's Food Guide. | Behavioural | Guidelines-based physical activity and healthy eating |
| Guidelines-based physical activityThrough 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. | Behavioural | Guidelines-based physical activity, Guidelines-based physical activity and healthy eating |
| Stretching exerciseTwice weekly virtual instructor-led whole-body stretching. | Behavioural | Stretching exercise |
Primary outcome
Insulin resistance
Time frame: 6 months
As assessed by the Matsuda Index calculated from an oral glucose tolerance test (OGTT).
3 secondary outcomes
Hepatic insulin resistance
Time frame: 6 months
Metabolic syndrome severity
Time frame: 6 months
Framingham 10-year risk (%)
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amy A Kirkham, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guidelines-based healthy eating, Guidelines-based physical activity and Stretching exercise in people with Metabolic Disturbance and Sedentary Behavior, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amy A Kirkham, PhD (416-946-4069, amy.kirkham@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin resistance (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.