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Eating within a window may shield breast cancer Survivors' brains and hearts

NCT ID NCT07259434

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether time-restricted eating (eating only during certain hours) can improve heart and brain health in 152 women aged 60-85 who finished chemotherapy for early-stage breast cancer at least a year ago. Participants will get counselling on when to eat and how to get enough protein. The goal is to see if this approach can lower heart disease risk and slow down memory and thinking problems.

What this could mean

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

Active substance
Time restricted eating (TRE) with protein intake counselling
What this could lead to
If it works, this could point toward a lifestyle approach to protect heart and brain health in older breast cancer survivors after chemotherapy.
What could go wrong
This is a small, early-stage study (152 participants) testing a behavioural change, not a drug. Results may not apply to all survivors, and sticking to the eating schedule may be hard for some.

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 152 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Oct 2028

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

60 to 85 years

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: * female * aged 60-85 years * BMI ≥25 kg/m2 * diagnosed with early-stage (I-III) BC in the past 15 years * received chemotherapy treatment that was completed ≥1 year earlier * Montreal Cognitive Assessment (MoCA) score of 10-30 which aligns with no impairment to moderate impairment thresholds. Exclusion Criteria: * does not have a mobile device that connects to Bluetooth and can send/receive text messages * history of physician-diagnosed heart disease, dementia or Alzheimer's disease, diabetes that requires insulin or sulfonylurea usage, or eating disorder * MoCA total score \<10 (indicating dementia) * ≥5kg weight change within past 3 months * taking lipid- or weight-lowering medication (e.g. statins or GLP-1 agonists) * high-risk for malnutrition (≥3 on the Malnutrition Screening Tool) * research MRI contraindications (e.g., pacemaker, breast tissue expander, magnetic implants) * eating all daily calories in \<10h/d in the past 3 months * following a structured dietary practice (e.g., ketogenic diet, Weight Watchers) or actively trying to lose weight in the past 3 months * being unable to make adjustments to eating time or nutrient intake * regularly doing \>90 min/week of moderate physical activity in the past 3 months * severe claustrophobia * BMI\>40 kg/m2 (due to body habitus fit within MRI scanner bore) * major psychiatric disorders (e.g. bipolar, post-traumatic stress disorder, schizophrenia) * neurological disorders that significantly impact physical or cognitive function (epilepsy, stroke, Parkinson's disease, multiple sclerosis, amyotrophic lateral sclerosis, muscular dystrophy) or traumatic brain injury resulting in ongoing neurological deficits. If the screening process identifies patients with undiagnosed severe cognitive function (MoCA score \<10) or at high risk for malnutrition (≥3 on the Malnutrition Screening Tool), the investigators will recommend that the individual see their family physician. In this process, the investigators will ask the participant if there is a family member that can also receive this information.

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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.

  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

    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

  • University of Toronto

    Toronto, Ontario, M5S 2C9, Canada

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