Time Restricted Eating in Haematological Malignancies

Phase 2

Not yet recruiting

• Conditions: Cancer; Chronic Lymphocytic Leukemia

• Registration Number: NCT06862323
• Lead Sponsor: British Columbia Cancer Agency

Brief 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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-03
• Study First Submitted QC: 2025-03-03
• Study First Posted: 2025-03-06
• Status Verified: 2025-06
• Study Start: 2025-06
• Last Update Submitted: 2025-06-11
• Last Update Posted: 2025-06-13
• Primary Completion: 2026-12
• Study Completion: 2027-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 75

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Epigenetic Analysis via PBMC Profiling	3 months	PBMC Profiling
Blood Sample Lymphocyte Count	3 months	Lymphocyte count assessment will be made at pre-intervention (within 3 months of the start of the IF study period), then monthly. If participants opt for a 90-day fast, blood collections will be completed on day 1, 30, 60, 90 and one month after completion of the TRE study period, to examine if TRE had an effect on lymphocyte numbers. Participants who opt for the 180-day fast will complete blood collections on day 1, 30, 60, 90, 120, 150 and 180. Blood collected at these time points will be analyzed for autophagy activation and for changes in immune, inflammatory, metabolic and epigenetic parameters.
Blood Sample Autophagy Flux Analysis	3 months	Participants will provide blood samples for autophagy flux analysis.
Microbiome Analysis of Stool Samples	3 months	Optionally, stool samples will be collected for microbiome analysis.

Secondary Outcome Measures

Name	Time	Method
Participant Experience: QLQ-30 and FACITF Questionnaires	3 months	Descriptive statistics will characterize study participants and quality of life indicators from QLQ-30 and FACITF questionnaires.

Trial Locations

Locations (1)

BC Cancer; 🇨🇦 Victoria, British Columbia, Canada