Clinical trial NCT06862323: Time Restricted Eating in Haematological Malignancies
Official title: Does Timing Matter? A Trial of Time Restricted Eating in Haematological Malignancies
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Cancer
Chronic Lymphocytic Leukemia
Keywords: Time Restricted Eating
Intermittent Fasting
Diet
Cancer
Chronic Lymphocytic Leukemia
Autophagy
Microbiome
Inflammation
Epigenetics
Lead sponsor: British Columbia Cancer Agency
Sponsor class: OTHER
Collaborators: name: BC Cancer Foundation
name: Michael Smith Foundation for Health Research
First posted: 2025-03-06
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A dietary intervention of intermittent fasting will be provided to the experimental arm of people with cancer and control arm of people without cancer.
Primary purpose: SUPPORTIVE_CARE

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)


Eligibility criteria: 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)

Primary outcomes:
measure: Blood Sample Lymphocyte Count
timeFrame: 3 months
measure: Blood Sample Autophagy Flux Analysis
timeFrame: 3 months
measure: Epigenetic Analysis via PBMC Profiling
timeFrame: 3 months
measure: Microbiome Analysis of Stool Samples
timeFrame: 3 months
Secondary outcomes:
measure: Participant Experience: QLQ-30 and FACITF Questionnaires
timeFrame: 3 months
Other outcomes:
Locations:
city: Victoria
country: Canada
facility: BC Cancer
state: British Columbia
Study officials:
affiliation: BC Cancer
name: Eleah Stringer, MSc, RD, CSO
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. 2024 Aug 30:nuae105. doi: 10.1093/nutrit/nuae105. Online ahead of print.