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Time Restricted Eating in Haematological Malignancies

StatusNot Yet Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Mar 2026 to Dec 2026 Start date: Mar 2025 to Jun 2025 · Primary endpoints revised (4) · Completion date: Oct 2026 to Aug 2027 · 4 morev2 Show 7 more changesShow less
    • Start date: Mar 2025 to Jun 2025
    • Primary endpoints revised (4)
    • Completion date: Oct 2026 to Aug 2027
    • Eligibility criteria revised
    • Secondary endpoint revised
    • Site contact updated
    • Collaborators revised (2)

    See this version in full on ClinicalTrials.gov ↗

  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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)
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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov