NCT07259434

Time Restricted Eating in Survivors Trial 2.0

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 152 (estimated)
• Sponsor: University of Toronto · Academic / Other
• Sex: Female
• Age: 60 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study will be a two-centre (University of Toronto and University of Alberta), two-arm, parallel-group, randomized controlled trial in older (60+ years) breast cancer survivors. 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). To standardize the potential participant bias toward healthy lifestyle changes and pre-existing physical activity tracking devices (i.e., Fitbits are common in this demographic), all participants will receive Canada's Food Guide, the Canadian 24-h movement guidelines, and a Garmin smartwatch at baseline. To enhance recruitment and retention, and in consideration of ethics of denying care to patients with elevated CVD risk, study staff will provide both groups with standardized healthy eating education following material from Canada's Food Guide 'Resources for Health Professionals' which aligns with dietary patterns that improve cardiovascular health. The investigators will standardize the type and frequency of intervention support across both groups but with differences in content. Support will consist of an initial call and check-in calls at weeks 1, 3, 6, 12 and daily text messages to act as a reminder, self-monitoring tool, and collect adherence. After the 16-week intervention, no further formal study support will be provided for participants. Participants will be informed they can continue to follow the interventions to the extent they choose for the next 6 months and that the investigators will contact them for one final assessment around that time. In-person study visits will include a \~4.5-h comprehensive assessment at baseline and again at 16 weeks, and one abbreviated \~2-h assessment at 40 weeks as a 24-week follow-up.

Conditions

• Breast Cancer
• Cardiovascular Risk
• Cognitive Function
• Physical Function

Interventions

Type	Name	Description
BEHAVIORAL	Time Restricted Eating	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).
BEHAVIORAL	Healthy Eating Education	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).

Timeline

• Start date: 2026-01-01
• Primary completion: 2028-09-30
• Completion: 2028-10-31
• First posted: 2025-12-02
• Last updated: 2025-12-02

Locations

1 site across 1 country: Canada