Time Restricted Eating in Survivors Trial 2.0

NCT07259434 | Not Yet Recruiting

• 1 other identifier: REB#47136
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Cardiovascular Risk; Cognitive Function; Physical Function

Keywords

Treatment; Prevention

Outcome Measures

Primary Outcomes (1)

• Framingham Risk Score (10-year)

  Calculated using the Canadian Cardiovascular Society's standardized scoring system where sex-specific points are assigned to age, systolic blood pressure (dependent on treatment status), HDL, total cholesterol, smoking and diabetes status. The range for females is 0-30% where a higher score indicates a greater risk of cardiovascular disease in the next 10 years.

  16 weeks

Secondary Outcomes (8)

• Cognitive Impairment

  16 weeks

• Cognitive Function - Verbal Learning & Memory

  16 weeks

• Cognitive Function - Processing Speed

  16 weeks

• Cognitive Function - Verbal Fluency

  16 weeks

• Cognitive Function - Cognitive Flexibility and Attention

  16 weeks

Other Outcomes (48)

• Framingham Risk Score (10-year)

  6 months

• Hemoglobin (HbA1c)

  16 weeks

• Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)

  16 weeks

Study Arms (2)

Time Restricted Eating

EXPERIMENTAL

The TRE group will be asked to restrict the time they consume food to an 8-h window starting at any time of the day and ending ≥3-h before bed, every day for 16 weeks.

Behavioral: Time Restricted Eating

Healthy Eating Education

ACTIVE COMPARATOR

The healthy eating education group will be asked not to make major changes to the timing or number of meals they consume every day for 16 weeks.

Behavioral: Healthy Eating Education

Interventions

Time Restricted Eating BEHAVIORAL

Participants receive remote counselling on TRE and protein intake. A registered dietitian (RD) will provide counselling on protein intake to mitigate potential decreases seen with TRE. The RD will provide participants with an individualized protein intake goal and will encourage them to work toward, or maintain, consuming at least 1.2 g/kg/day. Participants will receive a reference manual with a list of foods, serving sizes and protein content to help with achieving their protein intake goal. During the intervention, participants will be asked to respond to twice-daily automated text messages with the times they started and stopped eating on that day. TRE adherence will be determined as % of days where participant responses indicate fasting for ≥16h. Protein intake adherence assessed by the RD from the 24-h diet recall. Participants will also be asked to respond with a Likert ranking (1-5) to nutrition-related texts stemming from Health Canada dietary recommendations (same as control).

Time Restricted Eating

Healthy Eating Education BEHAVIORAL

The initial call (week 0) will focus on healthy eating education. Each check-in call will include continued healthy eating education, collection of adverse events related to the intervention and assessment of TRE contamination (via 24-h diet recall and reporting of number and timing of meals). This information will be recorded for comparison to the TRE group and across the intervention period. To standardize the use of daily text messages and enhance study engagement, participants in the TRE and the healthy eating education groups will both be asked to respond with a Likert ranking (1-5) to a nutrition-related question stemming from the Health Canada dietary recommendations on healthy eating (e.g. "Enjoying your food is part of healthy eating. How much do you enjoy the taste of your food?" Respond with 1 to 5 where 1=do not enjoy and 5=enjoy very much).

Healthy Eating Education

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Toronto: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

University of Toronto

Toronto, Ontario, M5S 2C9, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Amy A Kirkham, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy A Kirkham, PhD

CONTACT

416-946-4069; amy.kirkham@utoronto.ca

Courtney R Chang, PhD

CONTACT

416-946-8990; courtney.chang@utoronto.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Individuals analyzing vascular outcome data
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomly allocated to one of two groups for 16-weeks: 1) time restricted eating group + protein counselling and healthy eating education (intervention group) or 2) healthy eating education (comparison group). Participants will be randomized using an internet-based randomization service, with equal allocation to the two groups using permutated blocks with random block sizes of 2 \& 4, stratified by study site, protein intake (equal to or above vs below 1.2 g/kg/day) and Framingham Risk Score (FRS; low vs moderate-high). Blinding participants to the intervention is not possible, which introduces response bias on patient-reported outcomes.

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: December 2, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): October 31, 2028
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)