NCT06862323Not yet recruitingPhase 2
Time Restricted Eating in Haematological Malignancies
Does Timing Matter? A Trial of Time Restricted Eating in Haematological Malignancies
Source: ClinicalTrials.gov · Last updated 13 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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)
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- First submitted
- 3 Mar 2025
- Start date
- Jun 2025
- Primary completion date
- Dec 2026
- Lead sponsor
- British Columbia Cancer Agency
- Diseases
- Chronic lymphocytic leukaemia
- NCT number
- NCT06862323
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 75
- From Jun 2025 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- On medications required to be taken with food during the fasting window
- Anti-lymphoma therapy within the past 3 months
- Expected to initiate anti-lymphoma therapy within the next 3 months
Other illness
- Diabetes mellitus
- Unable to fast due to a digestive system disorder
Age
- \> 85 years of age (due to frailty, increased risk of infection, and burden of additional blood collections)
Other
- Experimental and Control Participants:
- Unable to give consent
- Pregnant or breastfeeding
- BMI drop to \< 18.5kg/m2 at any time during study
Who the study is looking for
- 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
Age in the registry: 18 years to 85 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| BC Cancer Coordinator of this site? Confirm its status | Victoria | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.