Tests time-restricted eating in people with chronic lymphocytic leukemia
Tests whether time-restricted eating affects cancer cell counts in adults with chronic lymphocytic leukemia.
Plain-language title generated from the registry record
Registry title: Time Restricted Eating in Haematological Malignancies
Key facts
- Where
- Victoria, CanadaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT06862323, who can take part
Where in Canada
- BC CancerVictoria, CanadaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- British Columbia Cancer Agency
- Trial code
- NCT06862323
- Record updated
- 13 June 2025
- Original description
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:Read full original descriptionShow less
Does Timing Matter? A Trial of Time Restricted Eating in Haematological Malignancies
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)
Inclusion: 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: On medications required to be taken with food during the fasting window; Anti-lymphoma therapy within the past 3 months; Expected to initiate anti-lymphoma therapy within the next 3 months; Diabetes mellitus; 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); Experimental and Control Participants:; Unable to give consent; Pregnant or breastfeeding; BMI drop to < 18.5kg/m2 at any time during study.