Time Restricted Eating in Haematological Malignancies

NCT06862323 | Not Yet Recruiting Phase 2

• 1 other identifier: H24-01236
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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)

Conditions

Cancer; Chronic Lymphocytic Leukemia

Keywords

Time Restricted Eating; Intermittent Fasting; Diet; Cancer; Chronic Lymphocytic Leukemia; Autophagy; Microbiome; Inflammation; Epigenetics

Outcome Measures

Primary Outcomes (4)

• Blood Sample Lymphocyte Count

  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.

  3 months

• Blood Sample Autophagy Flux Analysis

  Participants will provide blood samples for autophagy flux analysis.

  3 months

• Epigenetic Analysis via PBMC Profiling

  PBMC Profiling

  3 months

• Microbiome Analysis of Stool Samples

  Optionally, stool samples will be collected for microbiome analysis.

  3 months

Secondary Outcomes (1)

• Participant Experience: QLQ-30 and FACITF Questionnaires

  3 months

Study Arms (2)

Experimental Group

EXPERIMENTAL

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.

Behavioral: Time-Restricted Eating

Control Group

ACTIVE COMPARATOR

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.

Behavioral: Time-Restricted Eating

Interventions

Time-Restricted Eating BEHAVIORAL

TRE will be defined as a 16 hour fast with an 8 hour feeding window, with the option of a longer feeding window one day per week. All participants will adhere to the fasting intervention for either 90 days (3 months) or 180 days (6 months) based on their preference. Participants will be provided guidance (see appendix 7, Fasting Guidelines) on how to achieve an 8 hour feeding window by day 9 of the study and are recommended to adhere to the 16 hour fast/8 hour feeding window daily for the remainder of the study.

Control Group; Experimental Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• British Columbia Cancer Agency: lead
• BC Cancer Foundation: collaborator
• Michael Smith Foundation for Health Research: collaborator

Study Sites (1)

BC Cancer

Victoria, British Columbia, V8R 6V5, Canada

Location

Related Publications (1)

• Stringer EJ, Cloke RWG, Van der Meer L, Murphy RA, Macpherson NA, Lum JJ. The Clinical Impact of Time-restricted Eating on Cancer: A Systematic Review. Nutr Rev. 2025 Jul 1;83(7):e1660-e1676. doi: 10.1093/nutrit/nuae105.

  PMID: 39212676 BACKGROUND

Related Links

• Description of research program

MeSH Terms

Conditions

Neoplasms; Leukemia, Lymphocytic, Chronic, B-Cell; Intermittent Fasting; Inflammation

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fasting; Feeding Behavior; Behavior

Study Officials

• Eleah Stringer, MSc, RD, CSO

  BC Cancer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eleah Stringer, MSc, RD, CSO

CONTACT

1-250-519-5523; eleah.stringer@bccancer.bc.ca

Nicol Macpherson, MD, PhD, FRCPC

CONTACT

nmacpher5@bccancer.bc.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical and Research Dietitian

Model Details: A dietary intervention of intermittent fasting will be provided to the experimental arm of people with cancer and control arm of people without cancer.

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 6, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR, ANALYTIC CODE
• Time Frame: Will be available upon study completion (estimated date of September 2027) and will remained available for 10 years.
• Access Criteria: The aforementioned data will be made publicly available following study completion via OpenScienceFramework webpage. Additional data may be shared upon requested to study Principal Investigator.

Locations

CA (1)