Time-Restricted Eating for Cancer

Recruiting in Palo Alto (17 mi)

Overseen byEleah Stringer, MSc, RD, CSO

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: British Columbia Cancer Agency

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of 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 is for patients with chronic lymphocytic leukemia (CLL) or other hematological malignancies like lymphoma. Participants should be willing to follow a 16/8 fasting regimen, provide blood samples, and complete questionnaires. They must not have conditions that make fasting unsafe.

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

I have never had cancer, am aged 18-85, have a healthy weight and physical ability, and haven't fasted recently.

Exclusion Criteria

Pregnant or breastfeeding

BMI drop to < 18.5kg/m2 at any time during study

I have diabetes.

+6 more

Participant Groups

The study tests if time-restricted eating (TRE), an intermittent fasting method where participants eat normally for 8 hours and fast for the remaining 16 hours daily, affects cancer cell counts, immune cell autophagy activity, and improves quality of life in CLL patients.

2Treatment groups

Experimental Treatment

Active Control

Group I: Experimental GroupExperimental Treatment1 Intervention

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). 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. 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.

Group II: Control GroupActive Control1 Intervention