AzTrials
AzTrials

CancerPhase 2NCT06862323

Time Restricted Eating in Haematological Malignancies

A Phase 2 study testing Time-Restricted Eating in people with Cancer and Chronic Lymphocytic Leukemia, run by British Columbia Cancer Agency at 1 site in Canada.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Cancer, Chronic Lymphocytic Leukemia
What is being tested?
Time-Restricted Eating
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteCanada
Study dates
Jun 2025to Aug 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 14Show fewer
  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Eleah Stringer, MSc, RD, CSO contact

1-250-519-5523

eleah.stringer@bccancer.bc.ca

Nicol Macpherson, MD, PhD, FRCPC contact

nmacpher5@bccancer.bc.ca

Canada1 site

  • BC Cancer

    Victoria, British Columbia, V8R 6V5

    Eleah Stringer, 1-250-519-5523, eleah.stringer@bccancer.bc.ca

    Nicol Macpherson, nmacpher5@bccancer.bc.ca

Other trials in Canada

About this study

Official title: 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?
Read more

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)
Being tested
Time-Restricted Eating
Keywords
Time Restricted Eating, Intermittent Fasting, Diet, Cancer, Chronic Lymphocytic Leukemia, Autophagy, Microbiome, Inflammation, Epigenetics
Medical subject headings
Neoplasms, Leukemia, Lymphocytic, Chronic, B-Cell, Intermittent Fasting, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Time-Restricted EatingBehavioural

    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.

Study groups in NCT06862323
Study groupRoleWhat they receive
Experimental GroupExperimentalResearch 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.
Receives: Behavioral: Time-Restricted Eating
Control GroupActive comparatorThe 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.
Receives: Behavioral: Time-Restricted Eating

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 months

  2. Blood Sample Autophagy Flux Analysis

    Participants will provide blood samples for autophagy flux analysis.

    Measured: 3 months

  3. Epigenetic Analysis via PBMC Profiling

    PBMC Profiling

    Measured: 3 months

  4. Microbiome Analysis of Stool Samples

    Optionally, stool samples will be collected for microbiome analysis.

    Measured: 3 months

Secondary outcomes (1)

  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.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2025
  2. Study startJun 2025 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionAug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06862323
Sponsor's protocol ID
H24-01236
Status last verified
Jun 2025
First submitted
3 Mar 2025
Last updated
13 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD will be available through OSF upon study completion. The protocol will be published.

Publications

  • 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. 2025 Jul 1;83(7):e1660-e1676. doi: 10.1093/nutrit/nuae105.

    PubMed 39212676

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Time-Restricted Eating in people with Cancer and Chronic Lymphocytic Leukemia, run by British Columbia Cancer Agency at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Eleah Stringer, MSc, RD, CSO (1-250-519-5523, eleah.stringer@bccancer.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood Sample Lymphocyte Count (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06862323, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025; AzTrials last refreshed its copy on 1 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in