Cancer, Chronic Lymphocytic Leukemia
Conditions
Keywords
Time Restricted Eating, Intermittent Fasting, Diet, Cancer, Chronic Lymphocytic Leukemia, Autophagy, Microbiome, Inflammation, Epigenetics
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)
Interventions
BEHAVIORALTime-Restricted Eating
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.
Sponsors
BC Cancer Foundation
Michael Smith Foundation for Health Research
British Columbia Cancer Agency
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Sample Lymphocyte Count | 3 months | 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. |
| Blood Sample Autophagy Flux Analysis | 3 months | Participants will provide blood samples for autophagy flux analysis. |
| Epigenetic Analysis via PBMC Profiling | 3 months | PBMC Profiling |
| Microbiome Analysis of Stool Samples | 3 months | Optionally, stool samples will be collected for microbiome analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant Experience: QLQ-30 and FACITF Questionnaires | 3 months | Descriptive statistics will characterize study participants and quality of life indicators from QLQ-30 and FACITF questionnaires. |
Countries
Canada
Contacts
Primary ContactEleah Stringer, MSc, RD, CSO
Backup ContactNicol Macpherson, MD, PhD, FRCPC
Outcome results
None listed