Time-Restricted Eating for Cancer

Overseen By Eleah Stringer, MSc, RD, CSO

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: British Columbia Cancer Agency

Must not be taking: Food-required medications

Disqualifiers: Diabetes, Pregnancy, Anti-lymphoma therapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 3-6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether time-restricted eating (TRE), a form of intermittent fasting, can benefit individuals with chronic lymphocytic leukemia (CLL). Researchers aim to determine if an 8-hour eating window followed by a 16-hour fast can lower or stabilize cancer cell counts, reduce autophagy, and enhance quality of life. Individuals with CLL who are not yet receiving treatment and can fast may be suitable candidates. Participants will track their meals, provide blood samples, and complete quality of life surveys over 3 to 6 months. Community members without cancer will also participate for comparison. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on medications that must be taken with food during the fasting period.

Is there any evidence suggesting that time-restricted eating is likely to be safe for humans?

Research has shown that time-restricted eating (TRE) is generally safe. In one study, most participants adhered to the TRE schedule, with rates between 67% and 98%. Another study found TRE safe and manageable for patients with head and neck cancer, enhancing the effectiveness of their other treatments. Additionally, a study on breast cancer survivors found that eating within an 8-hour window and fasting for 16 hours was both safe and practical, reducing their risk of heart disease.

These findings suggest that TRE is well-tolerated by various groups, including cancer patients. While individual experiences may vary, evidence indicates that TRE is safe for many people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Time-Restricted Eating (TRE) is unique because it offers a non-pharmacological approach to managing cancer, specifically early-stage chronic lymphocytic leukemia (CLL). Unlike traditional treatments such as chemotherapy or targeted therapies, which directly attack cancer cells, TRE focuses on optimizing the body's natural rhythms by limiting food intake to an 8-hour window each day. This method aims to enhance metabolic health and potentially improve the body's response to cancer through mechanisms like enhanced autophagy, which can promote the removal of damaged cells. Researchers are excited about TRE because it could offer a complementary strategy that might improve quality of life and outcomes without the side effects associated with conventional cancer treatments.

What evidence suggests that time-restricted eating might be an effective treatment for chronic lymphocytic leukemia?

Research has shown that time-restricted eating (TRE), a type of intermittent fasting, might benefit cancer patients, including those with chronic lymphocytic leukemia (CLL). In earlier studies, participants who followed a TRE schedule reported increased energy, improved well-being, and better sleep. Notably, 47% of participants experienced a decrease or stabilization in their cancer cell counts. In this trial, the experimental group will follow a TRE schedule to assess its impact on cancer management. TRE has also been linked to an improved quality of life for some cancer patients. These findings suggest that TRE could be a useful strategy for managing CLL and enhancing overall health. ^{1 6 7 8 9}

Who Is on the Research Team?

Eleah Stringer, MSc, RD, CSO

Principal Investigator

BC Cancer

Are You a Good Fit for This Trial?

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

Exclusion Criteria

Pregnant or breastfeeding

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

I have diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants adhere to a 16/8 fasting regimen for either 3 or 6 months, complete monthly blood collections, weekly journal entries, and safety check-ins.

3-6 months

Weekly safety check-ins for the first 4 weeks, then bi-weekly; monthly blood collections

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a follow-up blood collection one month after completion of the TRE study period.

1 month

Optional End of Study Interview

Participants may complete an optional end of study interview to discuss their experience.

What Are the Treatments Tested in This Trial?

Interventions

• Time-Restricted Eating

Trial Overview 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.

How Is the Trial Designed?

Group I: Experimental Group Experimental Treatment 1 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). 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 Group Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

British Columbia Cancer Agency

Lead Sponsor

Trials

181

Recruited

95,900+

BC Cancer Foundation

Collaborator

Trials

20

Recruited

8,600+

Michael Smith Health Research BC

Collaborator

Trials

2

Recruited

480+

Michael Smith Foundation for Health Research

Collaborator

Trials

20

Recruited

6,100+

Published Research Related to This Trial

In a study involving 15 men over 8 weeks, time-restricted eating (TRE) significantly altered 24-hour profiles of key metabolic markers, including insulin and triglycerides, suggesting potential benefits for metabolic health.

TRE also influenced the expression of genes related to circadian rhythms and transcriptional regulation in subcutaneous adipose tissue, indicating a mechanism by which TRE may improve metabolic function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-restricted eating alters the 24-hour profile of adipose tissue transcriptome in men with obesity. Zhao, L., Hutchison, AT., Liu, B., et al.[2023]

Short-term dietary restriction, involving alternate day feeding and fasting, significantly improved survival rates in tumor-bearing Fisher rats, with 66.7% surviving 9 days post-tumor inoculation compared to only 20.8% in the control group.

The study suggests that mild dietary restrictions could be beneficial in enhancing survival and potentially inhibiting cancer growth, indicating a need for further clinical trials in human cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of short-term dietary restriction on survival of mammary ascites tumor-bearing rats. Siegel, I., Liu, TL., Nepomuceno, N., et al.[2019]

In a 12-week study involving 14 adults with obesity, time-restricted feeding (8-hour eating window) led to a significant weight loss of about 2 kg, indicating potential efficacy for weight management.

Despite the weight loss, the study found no significant changes in the diversity or composition of the gut microbiome, suggesting that time-restricted feeding may not impact gut health in terms of microbial diversity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of time restricted feeding on the gut microbiome in adults with obesity: A pilot study. Gabel, K., Marcell, J., Cares, K., et al.[2022]

Time-restricted feeding (TRF) significantly reduces the risk of obesity-related metastasis in a mouse model of lung cancer, as shown by lower numbers and sizes of lung metastases compared to those on a high-fat diet (HFD).

TRF also effectively prevents increases in harmful substances like glucose, insulin, and proinflammatory cytokines that are typically elevated by a high-fat diet, suggesting a protective mechanism against cancer progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-restricted Feeding Attenuates High-fat Diet-enhanced Spontaneous Metastasis of Lewis Lung Carcinoma in Mice. Yan, L., Sundaram, S., Mehus, AA., et al.[2019]

Time-restricted eating (TRE) is a promising dietary approach that not only aids in weight management but also positively influences energy metabolism, gut microbiota, and overall homeostasis.

Chronodisruption, which occurs when our internal circadian rhythms are out of sync with external cues, is linked to serious health issues like metabolic disorders and cancer, highlighting the importance of aligning eating patterns with our biological clocks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-restricted eating for chronodisruption-related chronic diseases. Cheng, WY., Desmet, L., Depoortere, I.[2023]

Time-restricted eating (TRE) has shown promising therapeutic effects in rodent studies, particularly in relation to body weight and metabolic health, but results in humans are inconsistent due to varying study designs and populations.

This review highlights the need for more standardized research on TRE in humans to better understand its effects and interactions with circadian biology, as well as to identify gaps in current knowledge for future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complex physiology and clinical implications of time-restricted eating. Petersen, MC., Gallop, MR., Flores Ramos, S., et al.[2023]

Time-restricted feeding (TRF) significantly reduced the expression of genes related to lipid metabolism in mammary tumors, suggesting a potential mechanism for its protective effects against tumor development.

Despite TRF not altering the overall metabolic profile of the tumors, its protective effects may be due to changes in the host's biological pathways rather than direct effects on tumor metabolism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolome of Mammary Tumors Differs from Normal Mammary Glands But Is Not Altered by Time-restricted Feeding Under Obesogenic Conditions. Yan, L., Sundaram, S., Rust, BM., et al.[2020]

This study is the first to evaluate the effects of time-restricted eating (TRE) on weight loss in a controlled manner, comparing it to a usual eating pattern (UEP) while ensuring both groups consumed the same number of calories and identical diets.

Participants aged 21-69 with prediabetes and obesity were monitored closely, allowing for a rigorous assessment of how meal timing impacts weight change without altering caloric intake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and Implementation of a Time-Restricted Eating Intervention in a Randomized, Controlled Eating Study. White, K., Wu, B., Pilla, SJ., et al.[2023]

In an 8-week study of time-restricted feeding (TRF) involving 32 women (13 premenopausal and 19 postmenopausal), both groups experienced similar weight loss of about 3.3% without any significant differences between them.

Both premenopausal and postmenopausal women showed reductions in fat mass, lean mass, fasting insulin, and oxidative stress markers, indicating that TRF can provide metabolic benefits regardless of menopausal status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in body weight and metabolic risk during time restricted feeding in premenopausal versus postmenopausal women. Cienfuegos, S., Gabel, K., Kalam, F., et al.[2023]

In a study involving 172 women undergoing chemotherapy, intermittent energy restriction (IER) showed a trend towards greater weight and body fat reduction compared to continuous energy restriction (CER), particularly after adjusting for body water.

While the overall incidence of severe chemotherapy toxicities was similar between IER and CER, there was a trend indicating fewer severe toxicities in the IER group during later cycles of treatment, suggesting IER may help reduce treatment-related side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised controlled trial of intermittent vs continuous energy restriction during chemotherapy for early breast cancer. Harvie, M., Pegington, M., Howell, SJ., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12166167/

The Clinical Impact of Time-restricted Eating on Cancer Preliminary findings suggest that TRE is feasible and acceptable by people with cancer, may have oncological benefits, and improves quality of life.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04626843

NCT04626843 | Intermittent Fasting and CLL/SLL In previous studies, fasting was well-tolerated with notable improvements in energy levels, sense of well-being, and sleep quality. In cancer patients, clinical ...

3. mdpi.com mdpi.com/2673-6357/5/4/31

Fasting and Diet: Overview in Chronic Lymphocytic Leukemia This review aims to provide an overview of the potential impact of fasting and diet on cancer, and in particular, on chronic lymphocytic leukemia (CLL).

4. medrxiv.org medrxiv.org/content/10.1101/2024.12.16.24319108v1.full-text

Intermittent fasting alters tumor burden, autophagy, and ... Seven of fifteen participants (47%) experienced a decrease or stabilization in malignant lymphocyte counts on time-restricted eating, while ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06862323

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 ...

6. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.6051

Safety and efficacy of time restricted eating (TRE) in ... We report a novel phase I/II study of TRE in HNSCC patients and demonstrate excellent safety, feasibility and marked improvement in efficacy of ICB.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05259410

Time Restricted Eating During Chemotherapy for Breast ... The proposed research will demonstrate that time restricted eating, a form of intermittent fasting, will improve treatment related outcomes, patient related ...

8. academic.oup.com academic.oup.com/jnci/article-abstract/117/7/1311/7922559

Time-restricted eating and cancer: lessons learned and ... Time-restricted eating is a type of intermittent fasting. Food can be consumed as desired during the eating period but not during the remainder of the day.

9. ahajournals.org ahajournals.org/doi/10.1161/circ.144.suppl_1.12484

Abstract 12484: Weekday 16:8 Time-Restricted Eating in ... Eight weeks of weekday 16:8 TRE is highly feasible, safe, and reduces CVD risk among older breast cancer survivors with overweight/obesity at moderate CVD risk.