Time Restricted Eating in Haematological Malignancies (NCT06862323) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Time Restricted Eating in Haematological Malignancies
Canada75 participantsStarted 2025-06
Plain-language 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)
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.