Time Restricted Eating in Survivors Trial 2.0 (NCT07259434) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Time Restricted Eating in Survivors Trial 2.0
Canada152 participantsStarted 2026-01-01
Plain-language summary
After chemotherapy, older breast cancer survivors experience a faster decline in brain function. This can make it harder to enjoy life, stay social, and maintain independence. Chemotherapy can lead to poorer lifestyle habits, like unhealthy eating, less exercise, high stress, and poor sleep. Chemotherapy can also affect important health markers like blood sugar and cholesterol. Over time, these changes can damage blood vessels, which might lead to heart and brain issues. The investigators do not fully understand why brain function declines faster after chemotherapy, especially in older survivors, because there are many factors involved. In this study, the investigators will look at how lifestyle habits (like diet, exercise, stress and sleep), health markers (like blood sugar and cholesterol), and blood vessel health (like how well blood flows and how stiff the blood vessels are) affect brain function in older breast cancer survivors. The investigators will include 152 females aged 60-85 years, who finished chemotherapy for early-stage breast cancer at least 1 year ago. The investigators will use special tests to check different parts of brain function, like language, memory, and attention, as well as brain blood vessel health. This will help to understand which factors might speed up or slow down memory and thinking problems. Since many Canadian breast cancer survivors experience faster decline in brain function after chemotherapy, this study aims to find out what might make it worse. The results could help to create better and more personalized treatment plans for older breast cancer survivors that protect brain health and reduce problems with brain function in the future.
Who can participate
Age range
60 Years – 85 Years
Sex
FEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ph…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.