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| Name | Class |
|---|---|
| BC Cancer Foundation | OTHER |
| Michael Smith Foundation for Health Research | OTHER |
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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:
Immune cell autophagy activity in cancer patients will be compared to a subset of control participants without cancer.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | Research 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. |
|
| Control Group | Active Comparator | The 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Blood Sample Autophagy Flux Analysis | Participants will provide blood samples for autophagy flux analysis. | 3 months |
| Epigenetic Analysis via PBMC Profiling | PBMC Profiling | 3 months |
| Microbiome Analysis of Stool Samples | Optionally, stool samples will be collected for microbiome analysis. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Experience: QLQ-30 and FACITF Questionnaires | Descriptive statistics will characterize study participants and quality of life indicators from QLQ-30 and FACITF questionnaires. | 3 months |
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Inclusion Criteria:
Experimental Participants:
Control Participants:
Exclusion Criteria:
Experimental and Control Participants:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Eleah Stringer, MSc, RD, CSO | BC Cancer | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BC Cancer | Victoria | British Columbia | V8R 6V5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39212676 | Background | 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. |
| Label | URL |
|---|---|
| Description of research program | View source |
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IPD will be available through OSF upon study completion. The protocol will be published.
Will be available upon study completion (estimated date of September 2027) and will remained available for 10 years.
The aforementioned data will be made publicly available following study completion via OpenScienceFramework webpage. Additional data may be shared upon requested to study Principal Investigator.
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D000093763 | Intermittent Fasting |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
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A dietary intervention of intermittent fasting will be provided to the experimental arm of people with cancer and control arm of people without cancer.
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|
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |