Time Restricted Eating in Haematological Malignancies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Time-Restricted Eating.
- Who it may be relevant to
- Registry conditions: Cancer, Chronic Lymphocytic Leukemia. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Does Timing Matter? A Trial of Time Restricted Eating in Haematological Malignancies
Overview
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)
Interventions
- Behavioral Time-Restricted Eating
TRE will be defined as a 16 hour fast with an 8 hour feeding window, with the option of a longer feeding window one day per week. All participants will adhere to the fasting intervention for either 90 days (3 months) or 180 days (6 months) based on their preference. Participants will be provided guidance (see appendix 7, Fasting Guidelines) on how to achieve an 8 hour feeding window by day 9 of the study and are recommended to adhere to the 16 hour fast/8 hour feeding window daily for the remain
Primary outcome measures
- Blood Sample Lymphocyte Count [Time frame: 3 months]
- Blood Sample Autophagy Flux Analysis [Time frame: 3 months]
- Epigenetic Analysis via PBMC Profiling [Time frame: 3 months]
- Microbiome Analysis of Stool Samples [Time frame: 3 months]
Secondary outcome measures (1)
- Participant Experience: QLQ-30 and FACITF Questionnaires [Time frame: 3 months]
Eligibility criteria
Inclusion criteria
Experimental Participants:
- Diagnosis of CLL or SLL, Age 18-85
- Peripheral blood lymphocytes >20 x 10\^9/L
- Hemoglobin >90g/L
- Platelets ˃90 x 10\^9/L
- BMI of >=20kg/m2
- ECOG Performance Status >=2
- Not following any form of IF for 4 months prior to study
Control Participants:
- Absence of cancer diagnosis (active or historical)
- Age 18-85, Peripheral blood lymphocytes <5 x10\^9/L
- BMI of >=20kg/m2
- ECOG Performance Status >=2
- Not following any form of IF for 4 months prior to study
Exclusion criteria
Experimental and Control Participants:
- Unable to give consent
- On medications required to be taken with food during the fasting window
- Pregnant or breastfeeding
- Diabetes mellitus
- BMI drop to < 18.5kg/m2 at any time during study
- Anti-lymphoma therapy within the past 3 months
- Expected to initiate anti-lymphoma therapy within the next 3 months
- Unable to fast due to a digestive system disorder
- > 85 years of age (due to frailty, increased risk of infection, and burden of additional blood collections)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Canada · 1 center
- BC Cancer — Victoria
Publications
- Stringer EJ, Cloke RWG, Van der Meer L, Murphy RA, Macpherson NA, Lum JJ. The Clinical Impact of Time-restricted Eating on Cancer: A Systematic Review. Nutr Rev. 2025 Jul 1;83(7):e1660-e1676. doi: 10.1093/nutrit/nuae105. PMID 39212676
Identifiers
NCT: NCT06862323 · H24-01236