Time Restricted Eating in Survivors Trial 2.0

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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. Du
• Поведенческое 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

Первичные конечные точки

• Framingham Risk Score (10-year) [Срок оценки: 16 weeks]

Вторичные конечные точки (8)

• Cognitive Impairment [Срок оценки: 16 weeks]
• Cognitive Function - Verbal Learning & Memory [Срок оценки: 16 weeks]
• Cognitive Function - Processing Speed [Срок оценки: 16 weeks]
• Cognitive Function - Verbal Fluency [Срок оценки: 16 weeks]
• Cognitive Function - Cognitive Flexibility and Attention [Срок оценки: 16 weeks]
• Physical Function - Short Performance Battery [Срок оценки: 16 weeks]
• Physical Function - Six Minute Walk Test [Срок оценки: 16 weeks]
• Physical Function - Grip Strength [Срок оценки: 16 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• University of Toronto — Toronto

Идентификаторы

NCT: NCT07259434 · REB#47136

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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