Eating within a 10-hour window may shield breast cancer patients from heart-harming fat buildup
NCT ID NCT05432856
First seen Jul 20, 2026 · Last updated Jul 21, 2026 · Updated 1 time
Summary
This study tests whether a behavioral program — time-restricted eating, nutrition education, and reducing sedentary time — can prevent the unhealthy fat buildup that often occurs during chemotherapy for breast cancer. Researchers will measure changes in visceral and muscle fat using MRI, along with heart and metabolic health markers. The goal is to see if this lifestyle approach can lower the long-term risk of heart disease in breast cancer survivors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a behavioral program combining time-restricted eating (eating within an 8-10 hour window), nutrition education, and strategies to reduce sedentary time
- What this could lead to
- If it works, this approach could help breast cancer patients avoid long-term heart problems by preventing unhealthy fat gain during chemotherapy.
- What could go wrong
- This is a small early-stage study, so results may not apply to all patients. The intervention requires significant lifestyle changes, and adherence may be challenging.
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
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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
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About 65 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2024
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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: * Female biological sex at birth * \>18 years * Diagnosis of stage I, II, or III breast cancer * starting neoadjuvant or adjuvant intravenous chemotherapy * ECOG \<3; * Oncologist approval to participate; * English speaking (all study materials and study staff will be in English) * Willing and able to adhere to study intervention Exclusion Criteria: * Individuals who do not have access to a smart phone with Bluetooth capability (required for Fitbit and for responding to intervention text messages) or at least a shared cell phone with someone in the same household (i.e., some couples may share a phone). * Type 1 or type 2 diabetes who require exogenous insulin (due to the potential need to adjust insulin dosing with TRE) or with hemoglobin A1c \>10% * Research MRI contraindications (e.g., pacemaker, magnetic implants, pregnancy) * Uncontrolled thyroid disorder * Self-reported eating disorder history * Body mass index \<18.5 kg/m2 or clinical signs of cachexia (discretion of treating oncologist) * ≥5% body weight loss within last 6 months * Those who are currently working night/rotating shifts, eating within ≤10-hour window or consistently eating less than 3 meals/day in the past 3 months. * patients who meet the criteria for medical clearance prior to exercise using the Physical Activity Readiness Questionnaire+ and are not cleared by their treating oncologist or family physician to perform maximal exercise testing.
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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
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Alberta
RECRUITINGEdmonton, Alberta, T6G2R3, Canada
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University of Toronto
RECRUITINGToronto, Ontario, Canada
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