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Diet and exercise trial aims to cut heart risks for breast cancer survivors

NCT ID NCT06454864

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether following exercise and healthy eating guidelines can improve heart health and reduce metabolic problems in breast cancer survivors. Forty-five postmenopausal women who had breast cancer will be split into three groups: exercise only, exercise plus dietary counseling, or stretching. The goal is to see if these lifestyle changes lower insulin resistance and other heart disease risks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
guidelines-based healthy eating and physical activity
What this could lead to
If successful, this could show that combining exercise with dietary counseling helps breast cancer survivors lower their risk of heart disease and diabetes.
What could go wrong
This is a small early-stage trial with only 45 participants, so results may not apply to all survivors. The interventions are lifestyle changes, which can be hard to maintain long-term.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 45 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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 * 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • University of Toronto

    RECRUITING

    Toronto, Ontario, M5S 2C9, Canada

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