Health TrialsbyHealthPanel

Time Restricted Eating in Haematological Malignancies

ConditionsCancerChronic Lymphocytic Leukemia
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorBritish Columbia Cancer Agency

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Unable to give consent

On medications required to be taken with food during the fasting window

Pregnant or breastfeeding

Diabetes mellitus

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

75 Participants
are divided into 2 treatment groups
Group A: Experimental GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
3 months
2

Blood Sample Autophagy Flux Analysis

Participants will provide blood samples for autophagy flux analysis.

Time frame
3 months
3

Epigenetic Analysis via PBMC Profiling

PBMC Profiling

Time frame
3 months
4

Microbiome Analysis of Stool Samples

Optionally, stool samples will be collected for microbiome analysis.

Time frame
3 months

Secondary outcomes

1

Participant Experience: QLQ-30 and FACITF Questionnaires

Descriptive statistics will characterize study participants and quality of life indicators from QLQ-30 and FACITF questionnaires.

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

British Columbia Cancer Agency

Lead sponsor

BC Cancer Foundation

Collaborator

Michael Smith Foundation for Health Research

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: