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NCT Number: NCT06862323

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)

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

BC Cancer

Victoria, British Columbia, V8R 6V5, Canada

Location contact

Barbara Stefanska, Ph.D.

SUB_INVESTIGATOR

Eleah Stringer

CONTACT

[email protected]

1-250-519-5523

Julian Lum, Ph.D.

SUB_INVESTIGATOR

Nicol Macpherson

CONTACT

[email protected]

Nicol Macpherson, MD, PhD, FRCPC

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. Blood Sample Autophagy Flux Analysis

    Time frame: 3 months

    Participants will provide blood samples for autophagy flux analysis.

  3. Epigenetic Analysis via PBMC Profiling

    Time frame: 3 months

    PBMC Profiling

  4. Microbiome Analysis of Stool Samples

    Time frame: 3 months

    Optionally, stool samples will be collected for microbiome analysis.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Eleah Stringer, MSc, RD, CSO

CONTACT

[email protected]

1-250-519-5523

Nicol Macpherson, MD, PhD, FRCPC

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

British Columbia Cancer Agency

Other

Collaborators

  • BC Cancer Foundation
  • Michael Smith Foundation for Health Research

Registry information

Official study title

Does Timing Matter? A Trial of Time Restricted Eating in Haematological Malignancies

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 6, 2025
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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