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Impact of Metabolic Health Patterns And Breast Cancer Over Time in Women

RecruitingNAAges 18 Years - anyFemaleUniversity of Alberta
NCT05432856 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Background \& Rationale: Breast cancer (BC) is the most commonly diagnosed malignancy in women worldwide (2.1 million diagnoses in 2018, 25% of new cancer cases). In Canada, early stage BC mortality rates have decreased by 48% over the past 30 years as a result of advances in prevention, detection, and treatment. However, competing risks for mortality from non-cancer causes have emerged, where cardiovascular disease (CVD) is now a leading cause of death for BC survivors. The direct toxic effects of BC treatment on the heart (cardiotoxicity) are well characterized by the investigators and many others, as a contributor to elevated cardiovascular risk. However, BC treatment and the associated lifestyle changes (i.e. physical inactivity, poor diet quality, stress) are increasingly recognized to also strongly affect metabolism negatively manifesting as insulin resistance, dyslipidemia and ad

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📋 Eligibility rules (as published)
Inclusion Criteria: * Female biological sex at birth * \>18 years * Diagnosis of stage I, II, or III breast cancer * starting neoadjuvant or adjuvant intravenous chemotherapy * ECOG \<3; * Oncologist approval to participate; * English speaking (all study materials and study staff will be in English) * Willing and able to adhere to study intervention Exclusion Criteria: * Individuals who do not have access to a smart phone with Bluetooth capability (required for Fitbit and for responding to intervention text messages) or at least a shared cell phone with someone in the same household (i.e., some couples may share a phone). * Type 1 or type 2 diabetes who require exogenous insulin (due to the potential need to adjust insulin dosing with TRE) or with hemoglobin A1c \>10% * Research MRI contraindications (e.g., pacemaker, magnetic implants, pregnancy) * Uncontrolled thyroid disorder * Self-reported eating disorder history * Body mass index \<18.5 kg/m2 or clinical signs of cachexia (discretion of treating oncologist) * ≥5% body weight loss within last 6 months * Those who are currently working night/rotating shifts, eating within ≤10-hour window or consistently eating less than 3 meals/day in the past 3 months. * patients who meet the criteria for medical clearance prior to exercise using the Physical Activity Readiness Questionnaire+ and are not cleared by their treating oncologist or family physician to perform maximal exercise testing.
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What it tests

  • Time restricted eating, nutrition education, and sedentary time reduction strategies
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Where

2 sites
University of Alberta
Edmonton, Canada
University of Toronto
Toronto, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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