Breast CancerTEST2NCT07259434
Time Restricted Eating in Survivors Trial 2.0
A study testing Time Restricted Eating and Healthy Eating Education in people with Breast Cancer and Cardiovascular Risk, run by University of Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 85 years, women only
- Conditions the study is for
- Breast Cancer, Cardiovascular Risk, Cognitive Function
- What is being tested?
- Time Restricted Eating and Healthy Eating Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2026to 31 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
University of Toronto
Toronto, Ontario, M5S 2C9
Amy A Kirkham, PhD, 416-946-4069, amy.kirkham@utoronto.ca
Courtney R Chang, PhD, 416-946-8990, courtney.chang@utoronto.ca
About this study
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.
Read the 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.
- Being tested
- Time Restricted Eating, Healthy Eating Education
- Keywords
- Treatment, Prevention
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time Restricted EatingBehavioural
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).
Healthy Eating EducationBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Healthy Eating Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 weeks
Secondary outcomes (8)
Cognitive Impairment
Assessed by Global Deficit Score (GDS). GDS is calculated as an average score from 3 tests, as described in outcomes 3, 4 and 5 below: 1) Hopkins Verbal Learning Test, 2) Trail Making Test, and 3) Controlled Oral Word Association of the Multilingual Aphasia Exam, respecitvely. Each subtest consists of a complex scoring system, detailed below, with higher values indicating greater cognitive deficits.
Measured: 16 weeks
Cognitive Function - Verbal Learning & Memory
Assessed by the List Sorting Working Memory Test (working memory, 0-28 score range), Picture Sequence Memory Test (episodic memory, age-adjusted scale scores) and the Hopkins Verbal Learning Test (learning, memory) which includes an immediate recall, delayed recall, and recognition accuracy from a list of 12 words. Higher scores (number of correct words out of 12) are indicative of better cognitive health.
Measured: 16 weeks
Cognitive Function - Processing Speed
Assessed by the Trail Making Test (attention, speed, executive function). Shorter test time on 2 forms of the test is indicative of better cognitive function.
Measured: 16 weeks
Cognitive Function - Verbal Fluency
Assessed using the Controlled Oral Word Association of the Multilingual Aphasia Exam (verbal fluency). Higher total number of correct words produced within 60 seconds for each letter is indicative of better cognitive health.
Measured: 16 weeks
Cognitive Function - Cognitive Flexibility and Attention
The Dimensional Change Card Sorting test will be used to assess individual ability to switch between tasks or rules.
Measured: 16 weeks
Physical Function - Short Performance Battery
Participants will complete: 1) balance tests (stand for 10 sec with feet a) together, b) staggered and c) one in front of the other), 2) a chair stand test (the investigators will record how long it takes for participants to complete 5 sit to stand movements), and 3) a walking speed test (the investigators will record how long it take for participants to walk 3-4 meters at their normal walking speed). 0-12 score, with higher scores indicating higher function.
Measured: 16 weeks
Physical Function - Six Minute Walk Test
Participants will be instructed to walk as far as possible for 6 minutes between two cones that will be placed 30-m apart. Walking distance in meters is the main outcome of the 6MWT.
Measured: 16 weeks
Physical Function - Grip Strength
A grip strength assessment will also be administered using a dynamometer. Grip strength is commonly used in various cancer populations, including breast cancer, as a measure of upper body strength, and an indirect estimate of whole-body strength related to physical function. Dominant and non-dominant hand grip strength will be assessed as an average of 3 measurements on each side.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Amy Kirkham, University of Toronto
- Investigators
- Amy A Kirkham, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07259434
- Sponsor's protocol ID
- REB#47136
- Acronym
- TEST2
- Status last verified
- Nov 2025
- First submitted
- 26 Sep 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Restricted Eating in Survivors Trial 2.0
- ClinicalTrials.gov ID
- NCT07259434
- Acronym / sponsor ID
- TEST2 / REB#47136
- Keywords
- Treatment, Prevention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Time Restricted Eating | Experimental | Behavioral: Time Restricted EatingThe 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. |
| Healthy Eating Education | Active comparator | Behavioral: Healthy Eating EducationThe 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. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time Restricted EatingParticipants 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). | Behavioural | Time Restricted Eating |
| Healthy Eating EducationThe 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). | Behavioural | Healthy Eating Education |
Primary outcome
Framingham Risk Score (10-year)
Time frame: 16 weeks
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.
8 secondary outcomes
Cognitive Impairment
Time frame: 16 weeks
Cognitive Function - Verbal Learning & Memory
Time frame: 16 weeks
Cognitive Function - Processing Speed
Time frame: 16 weeks
Cognitive Function - Verbal Fluency
Time frame: 16 weeks
Cognitive Function - Cognitive Flexibility and Attention
Time frame: 16 weeks
Physical Function - Short Performance Battery
Time frame: 16 weeks
Physical Function - Six Minute Walk Test
Time frame: 16 weeks
Physical Function - Grip Strength
Time frame: 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amy A Kirkham, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time Restricted Eating and Healthy Eating Education in people with Breast Cancer and Cardiovascular Risk, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amy A Kirkham, PhD (416-946-4069, amy.kirkham@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Framingham Risk Score (10-year) (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.