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Time Restricted Eating in Haematological Malignancies

NCT06862323 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-06-13

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • BC Cancer Foundation

    collaborator OTHER

  • Michael Smith Foundation for Health Research

    collaborator OTHER

  • British Columbia Cancer Agency

    lead OTHER

Principal Investigators

  • Eleah Stringer, MSc, RD, CSO · BC Cancer

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2026-12-31
Completion
2027-08-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06862323 on ClinicalTrials.gov