Clinical Trial

Time Restricted Eating in Haematological Malignancies

Not Yet Recruiting Phase 2
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Summary
The goal of this clinical trial is to learn if time restricted eating (TRE), a form of intermittent fasting, can impact health outcomes in patients with chronic lymphocytic leukemia (CLL). The main questions it aims to answer are: * In patients with CLL, is there a decrease or stabilization in cancer cell counts associated with TRE compared to baseline? * Is there a decrease in immune cell autophagy (a cellular recycling process) activity associated with TRE compared to baseline? * Does adherence to a TRE regimen improve patient experience and quality of life? Immune cell autophagy activity in cancer patients will be compared to a subset of control participants without cancer. Participants will: * Adhere to a 16/8 fasting regimen, which involves eating as normal for 8 hours per day and fasting (only consuming water, black coffee or black tea) for the remaining 16 hours. They will follow this intervention for their choice of either 3 or 6 months. * Complete monthly blood collections * Complete weekly journal entries to record weekly weight and timing of first and last daily meals * Complete weekly safety check-ins with a study team member for the first 4 weeks of the study and then bi-weekly thereafter * Complete 3 quality of life questionnaires * Provide 3 stool samples (optional component of study) * Complete an end of study interview (optional component of study)
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-03-03.
Trial Details
NCT Number NCT06862323
Lead Sponsor British Columbia Cancer Agency
Collaborators: BC Cancer Foundation, Michael Smith Foundation for Health Research
Conditions Cancer, Chronic Lymphocytic Leukemia
Enrollment 75 participants
Start Date 2025-06
Primary Completion 2026-12 (estimated)
Study Completion 2027-08 (estimated)
Updated on ClinicalTrials.gov 2025-06-13