Time Restricted Eating in Haematological Malignancies

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 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)