Time Restricted Eating in Haematological Malignancies

British Columbia Cancer Agency

Status and phase: Not yet enrolling; Phase 2

Conditions: Chronic Lymphocytic Leukemia; Cancer

Treatments: Behavioral: Time-Restricted Eating

Study type: Interventional

Funder types: Other

Identifiers

NCT06862323

H24-01236

Details and patient eligibility

About

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)

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 2 patient groups

Experimental Group

Experimental group

Description:

Research Design: A nonrandomized control design will be followed with a 4:1 ratio (experimental: control). The experimental arm will consist of patients with early stage CLL who are on surveillance (n=60). Participants will follow a fasting intervention of an 8-hour feeding window with a 16-hour fasting window for a minimum of 6/7 days per week for either 3 months (90 days) or 6 months (180 days) based on their preference. Participants with cancer will provide blood samples, stool samples (optional) and will complete journals, check ins, and quality of life surveys per the schedule outlined in section 5.7 as well as in the attached study protocol document in section 6. Upon completion of study, participants with cancer may also complete an optional end of study interview.

Treatment:

Behavioral: Time-Restricted Eating

Control Group

Active Comparator group

Description:

The control arm will consist of community members who do not have cancer (n=15). Participants will follow a fasting intervention of an 8-hour feeding window with a 16-hour fasting window for a minimum of 6/7 days per week for either 3 months (90 days) or 6 months (180 days) based on their preference. Control participants will provide blood samples and weekly journals to serve as a control for autophagy flux analysis.

Treatment:

Behavioral: Time-Restricted Eating