Time Restricted Eating for Breast Cancer Survivors

(TEST2 Trial)

Overseen By Courtney R Chang, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Toronto

Must not be taking: Statins, GLP-1 agonists

Disqualifiers: Heart disease, Dementia, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how time-restricted eating affects brain function in older women who survived early-stage breast cancer and completed chemotherapy at least a year ago. Researchers examine how lifestyle habits and health markers, such as blood sugar and cholesterol, influence memory and thinking skills. Participants will either follow a time-restricted eating schedule or receive healthy eating education without altering meal timing. Women aged 60-85 who completed chemotherapy for early-stage breast cancer over a year ago and have a BMI of 25 or higher may be suitable candidates. As an unphased study, this trial allows participants to contribute to valuable research on lifestyle changes that may enhance cognitive health.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that time-restricted eating (TRE) is safe and well-tolerated for breast cancer survivors. In one study, participants who ate only during an 8-hour window each day for eight weeks found it manageable and safe after finishing chemotherapy. Another study found that this method helped lower the risk of heart problems in older survivors who were overweight or at risk for heart disease. These findings suggest that TRE can be a safe way to manage health after cancer treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about time-restricted eating (TRE) for breast cancer survivors because it offers a non-invasive, lifestyle-based approach to improving health outcomes. Unlike traditional treatments that might focus on medications or surgery, TRE simply involves limiting food intake to an 8-hour window each day, potentially leading to better metabolic health and weight management without the side effects of pharmaceuticals. Additionally, TRE could enhance the body's natural rhythms and improve sleep quality, which are crucial for recovery and overall well-being. This approach is particularly appealing because it empowers individuals to make dietary changes that fit their personal schedules, offering flexibility and potentially improving adherence to healthier habits.

What evidence suggests that time restricted eating might be an effective treatment for brain function decline in breast cancer survivors?

Research has shown that time-restricted eating (TRE), which participants in this trial may follow, might benefit breast cancer survivors. Women who fasted for less than 13 hours each night had a higher chance of breast cancer recurrence. Studies also suggest that TRE could reduce metabolic problems, potentially lowering overall cancer risks. Animal studies found that fasting might enhance chemotherapy effectiveness and reduce its side effects. Additionally, TRE could decrease the risk of heart disease, which is crucial for older breast cancer survivors. Overall, early evidence suggests that TRE might support better health and help protect brain function. ^{3 4 5 6 7}

Who Is on the Research Team?

Amy A Kirkham, PhD

Principal Investigator

University of Toronto

Are You a Good Fit for This Trial?

This trial is for female breast cancer survivors aged 60-85 who completed chemotherapy at least a year ago. It aims to understand how lifestyle habits and health markers influence brain function after treatment.

Inclusion Criteria

Montreal Cognitive Assessment (MoCA) score of 10-30 which aligns with no impairment to moderate impairment thresholds

BMI ≥25 kg/m2

I was diagnosed with stage I-III breast cancer within the last 15 years.

Exclusion Criteria

Severe claustrophobia

Does not have a mobile device that connects to Bluetooth and can send/receive text messages

MoCA total score <10 (indicating dementia)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Comprehensive assessment including cognitive and physical function tests, and distribution of study materials

1 day

1 visit (in-person)

Treatment

Participants are randomly allocated to either time restricted eating with protein counselling or healthy eating education for 16 weeks

16 weeks

5 check-in calls (weeks 1, 3, 6, 12, 16), daily text messages

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a final assessment at 40 weeks

24 weeks

1 visit (in-person) at 40 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Time Restricted Eating

Trial Overview The study tests the effects of Time Restricted Eating versus Healthy Eating Education on cardiovascular risk, cognitive functioning, and physical function in older breast cancer survivors.

How Is the Trial Designed?

Group I: Time Restricted Eating Experimental Treatment 1 Intervention

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.

Group II: Healthy Eating Education Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Toronto

Lead Sponsor

Trials

739

Recruited

1,125,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12229459/

Time-restricted eating and cancer: lessons learned ... Full achievement of the potential of time-restricted eating would lead to decreased metabolic dysfunction, with a reduction in cancer risk and increased ...

2. academic.oup.com academic.oup.com/nutritionreviews/article/83/7/e1660/7745808

Clinical Impact of Time-restricted Eating on Cancer Specifically, women who fasted for less than 13 hours per night were at increased risk of breast cancer recurrence compared with women who ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05259410

Time Restricted Eating During Chemotherapy for Breast ... Pre-clinical murine studies report intermittent fasting increases effectiveness of chemotherapy and decreases treatment related adverse events. The proposed ...

4. jacc.org jacc.org/doi/10.1016/j.jaccao.2022.03.002

Time-Restricted Eating to Reduce Cardiovascular Risk ... Time-restricted eating to reduce cardiovascular risk among older breast cancer survivors: a single-arm feasibility study.

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2021.39.15_suppl.12109

A 10-hour time-restricted eating intervention to address ... Conclusions: Cancer survivors were willing and able to adhere to a two-week time-restricted eating intervention, and the intervention was safe.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10404477/

a randomised controlled trial of the effect of time-restricted ... We recently demonstrated feasibility, safety and participant acceptability of 8 weeks of TRE in breast cancer survivors 3 years post-chemotherapy(24).

7. ahajournals.org ahajournals.org/doi/10.1161/circ.144.suppl_1.12484

Abstract 12484: Weekday 16:8 Time-Restricted Eating in ... Eight weeks of weekday 16:8 TRE is highly feasible, safe, and reduces CVD risk among older breast cancer survivors with overweight/obesity at moderate CVD risk.