Time-Restricted Eating for Cancer-related Fatigue

Overseen By Amber Kleckner

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Maryland, Baltimore

Must not be taking: Insulin

Disqualifiers: Underweight, Night shift, Surgery, 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: Unknown

Duration: 12 weeks

96 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether time-restricted eating, where participants consume all their food within a 10-hour window each day, can reduce fatigue in cancer survivors. Many cancer patients experience persistent tiredness that does not improve with rest, impacting daily activities and quality of life. Participants will either follow the time-restricted eating plan or receive guidance on general healthy eating without time restrictions. Those who have had blood cancer, completed treatment over two months ago, and still struggle with tiredness affecting daily life might be suitable for this trial. The study aims to determine if changing eating patterns can improve energy levels and overall well-being. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to potentially impactful findings.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications. You can continue taking your medicines at all times during the study.

What prior data suggests that time-restricted eating is safe for cancer-related fatigue?

Research has shown that time-restricted eating is generally safe for people with cancer. In one study, participants who followed this eating pattern felt significantly less tired by the end, suggesting it could help with cancer-related fatigue. Another study found that people with cancer considered time-restricted eating manageable and beneficial for their overall quality of life. These findings indicate that time-restricted eating is well-tolerated, with no major safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for cancer-related fatigue involve medications and lifestyle changes like exercise therapy and counseling. But time-restricted eating is unique because it focuses on when you eat rather than what you eat, aiming to align eating patterns with the body's natural circadian rhythms. Researchers are excited because this approach could potentially improve energy levels and reduce fatigue without the need for additional medications. Moreover, time-restricted eating is simple to implement and could offer a more holistic way to manage fatigue, benefiting overall well-being and potentially enhancing the effectiveness of existing treatments.

What evidence suggests that time-restricted eating might be an effective treatment for cancer-related fatigue?

Research shows that time-restricted eating (TRE), where people consume all meals within a 10-hour period, might help reduce cancer-related fatigue. Early results found that after just two weeks, cancer survivors felt less tired. This trial will compare TRE with time-unrestricted eating to evaluate its effectiveness. Studies also suggest that TRE may offer other benefits, such as improving quality of life and being easy for people with cancer to follow. By eating within a set time frame, TRE may help reset the body's internal clock, which cancer and its treatments might disrupt. This reset could be one reason why fatigue decreases. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for cancer survivors experiencing persistent fatigue that isn't helped by rest. Participants should be interested in adjusting their eating habits, willing to log food intake and weight using an app, and able to commit to a 12-week study with follow-ups.

Inclusion Criteria

Participants must be able to speak and/or read and write in English

I have been diagnosed with a blood cancer, such as leukemia, lymphoma, or multiple myeloma.

I often feel very tired.

Exclusion Criteria

Participants must not already eat all their food within a window that is 10 h or shorter most (6/7) days of the week

Participants must not be employed in a job where they regularly work away from the home at night (e.g., night shift)

I am not taking insulin.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 12-week intervention of time-restricted eating or an unrestricted eating pattern

12 weeks

Weekly virtual check-ins via the myCircadianClock app

Follow-up

Participants are monitored for sustainability of the program and effects on circadian rhythm and sugar metabolism

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Time-restricted eating

Trial Overview

The study compares the effects of time-restricted eating (consuming all food within a 10-hour window) versus no eating restrictions but following general nutrition guidelines. The goal is to see if when you eat affects cancer-related fatigue, body rhythms, and sugar processing.

How Is the Trial Designed?

Group I: Time-restricted eating Experimental Treatment 2 Interventions

Group II: Time-unrestricted eating Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Published Research Related to This Trial

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]

In a study involving adults with obesity, both 4-hour and 6-hour time-restricted feeding (TRF) regimens led to comparable weight loss of about 3% over 8 weeks, along with improvements in insulin resistance and oxidative stress.

Participants in the TRF groups reduced their daily energy intake by approximately 550 kcal without needing to count calories, suggesting that TRF can be an effective and manageable approach for weight loss and improving cardiometabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of 4- and 6-h Time-Restricted Feeding on Weight and Cardiometabolic Health: A Randomized Controlled Trial in Adults with Obesity. Cienfuegos, S., Gabel, K., Kalam, F., et al.[2022]

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]

A time-restricted eating (TRE) intervention was found to be feasible and safe for cancer survivors, with 92.3% of the 39 participants completing the study without severe adverse events.

Participants experienced a significant reduction in cancer-related fatigue after two weeks of TRE, with improvements in fatigue scores indicating a moderate effect size, suggesting that TRE may be a beneficial strategy for managing fatigue in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-restricted Eating to Address Cancer-related Fatigue among Cancer Survivors: A Single-arm Pilot Study. Kleckner, AS., Altman, BJ., Reschke, JE., et al.[2022]

Time-restricted eating (TRE), which limits calorie intake to 6- to 10-hour periods during the active part of the day, has been shown to improve various aspects of metabolic health, including weight loss, glucose tolerance, and cardiovascular health, based on both preclinical and human studies.

Implementing TRE can help mitigate the negative effects of eating out of sync with our body's natural circadian rhythms, potentially reducing the risk of chronic diseases, although there are challenges in applying this dietary approach in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-Restricted Eating: Benefits, Mechanisms, and Challenges in Translation. Regmi, P., Heilbronn, LK.[2021]

Modified alternate-day fasting (ADF) significantly reduces cell proliferation rates in various tissues, regardless of whether the diet is low-fat or high-fat, suggesting its potential as a cancer prevention strategy.

In a 4-week study with male mice, both ADF groups showed similar reductions in T-cell proliferation and decreased plasma insulin-like growth factor-1 levels, indicating that ADF can be effective across different dietary fat intakes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alternate-day fasting reduces global cell proliferation rates independently of dietary fat content in mice. Varady, KA., Roohk, DJ., Bruss, M., et al.[2009]

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]

A 4-week study on trained male endurance runners showed that a 16/8 time-restricted feeding (TRF) pattern led to a significant decrease in fat mass without affecting fat-free mass or running performance.

While the TRF group experienced lower carbon dioxide production and blood lactate levels during exercise, their 10 km time trial performance remained unchanged compared to those on a normal diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Four Weeks of 16/8 Time Restrictive Feeding in Endurance Trained Male Runners Decreases Fat Mass, without Affecting Exercise Performance. Tovar, AP., Richardson, CE., Keim, NL., et al.[2021]

Time-restricted eating (TRE) significantly reduces body weight and fat mass, with an average weight loss of 1.60 kg and fat loss of 1.48 kg in a meta-analysis of 17 studies involving 899 participants.

TRE particularly benefits overweight individuals, leading to improvements in lipid profiles, including lower triglycerides, total cholesterol, and LDL cholesterol, although it does not significantly affect waist circumference or blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolic Efficacy of Time-Restricted Eating in Adults: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Liu, L., Chen, W., Wu, D., et al.[2022]

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