Time Restricted Eating in Haematological Malignancies

June 11, 2025 updated by: Eleah Stringer, British Columbia Cancer Agency

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)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • British Columbia
      • Victoria, British Columbia, Canada, V8R 6V5
        • BC Cancer
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Julian Lum, Ph.D.
        • Sub-Investigator:
          • Barbara Stefanska, Ph.D.
        • Sub-Investigator:
          • Nicol Macpherson, MD, PhD, FRCPC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
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
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.
Active Comparator: Control Group
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Sample Lymphocyte Count
Time Frame: 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.
3 months
Blood Sample Autophagy Flux Analysis
Time Frame: 3 months
Participants will provide blood samples for autophagy flux analysis.
3 months
Epigenetic Analysis via PBMC Profiling
Time Frame: 3 months
PBMC Profiling
3 months
Microbiome Analysis of Stool Samples
Time Frame: 3 months
Optionally, stool samples will be collected for microbiome analysis.
3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

British Columbia Cancer Agency

Collaborators

BC Cancer Foundation
Michael Smith Foundation for Health Research

Investigators

  • Principal Investigator: Eleah Stringer, MSc, RD, CSO, BC Cancer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

March 3, 2025

First Submitted That Met QC Criteria

March 3, 2025

First Posted (Actual)

March 6, 2025

Study Record Updates

Last Update Posted (Actual)

June 13, 2025

Last Update Submitted That Met QC Criteria

June 11, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H24-01236

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD will be available through OSF upon study completion. The protocol will be published.

IPD Sharing Time Frame

Will be available upon study completion (estimated date of September 2027) and will remained available for 10 years.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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