Time-Restricted Eating for Cancer-Related Fatigue

Overseen By Amber Kleckner, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Must not be taking: Insulin

Disqualifiers: Underweight, Surgery planned, Type 1 diabetes, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether time-restricted eating can reduce cancer-related fatigue in cancer survivors. Participants will either follow a time-restricted eating plan, consuming all food within a 10-hour window, or receive general health tips without altering their eating schedule. The study seeks individuals who completed cancer treatments like chemotherapy or surgery in the last 2 years and are experiencing ongoing fatigue. Participants should own a smartphone and be willing to use it for the study. The goal is to determine if this eating pattern can ease fatigue and improve overall health. As an unphased study, this trial allows participants to contribute to innovative research that could enhance the quality of life for cancer survivors.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking insulin or have any contraindications to the nutrition intervention, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that time-restricted eating is safe for people with cancer. One study found it helped reduce fatigue without causing major side effects. Another study found it was not only feasible but also easy for participants to follow. These findings suggest that time-restricted eating could help lessen cancer-related fatigue while remaining safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for cancer-related fatigue focus on medications, physical therapy, or cognitive behavioral therapy. However, time-restricted eating, the treatment under study, is unique because it offers a non-invasive approach by regulating the timing of food intake rather than altering diet content. Participants choose a 10-hour window for eating, which may help sync their eating patterns with natural circadian rhythms, potentially improving energy levels and reducing fatigue. Researchers are particularly excited about this approach as it encourages a healthy lifestyle without the need for medication, making it a potentially easy and natural way to combat fatigue in cancer survivors.

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

Research has shown that time-restricted eating (TRE), a treatment under study in this trial, might help reduce tiredness in cancer survivors. Studies found that eating only during a 10-hour window each day can moderately improve fatigue. This method is safe and easy for cancer survivors to follow. It may also enhance overall well-being by helping to regulate the body's internal clock. Early results suggest that TRE could offer additional health benefits for those recovering from cancer. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for cancer survivors who are at least 18 years old, have completed their main treatments between 2 months and 2 years ago, can use a smartphone, speak English, and consent to study procedures. They must feel fatigued (score of 4+ on a scale of 0-10) but not be underweight or have conditions like type 1 diabetes that could complicate the diet intervention.

Inclusion Criteria

Be willing and able to adhere to study procedures, including use of a smartphone app

Own a smartphone

Be able to provide informed consent

Exclusion Criteria

I am currently taking insulin.

I do not have conditions like type 1 diabetes, risk for low blood sugar, specific medication needs, pregnancy, breastfeeding, or a recent eating disorder that would prevent me from following the study's diet plan.

Already eat all their food within a window that is 10 h or shorter most (6/7) days of the week

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 time-restricted eating intervention or receive general health education

12 weeks

Weekly educational tips (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Healthy lifestyle education
• Time-restricted eating

Trial Overview

The study tests if restricting eating to a 10-hour window each day for 12 weeks reduces fatigue in cancer survivors compared to those receiving general health education. Participants will be randomly assigned to either time-restricted eating or control group in equal numbers.

How Is the Trial Designed?

Group I: Time-restricted eating Experimental Treatment 2 Interventions

Participants will self-select a 10-hour window in which to consume all food and beverages (with the exception of black coffee and unsweetened tea in the mornings; water is okay at all times). Participants will also receive weekly tips to encourage a healthy lifestyle in cancer survivorship.

Group II: Control Experimental Treatment 1 Intervention

Participants will receive weekly tips to encourage healthy lifestyle behaviors in cancer survivorship.

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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) 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), 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]

Citations

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academic.oup.com

academic.oup.com/nutritionreviews/article/83/7/e1660/7745808

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.

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prevention.cancer.gov

prevention.cancer.gov/funding-and-grants/funded-grants/R01CA284082

Funded Grants | Division of Cancer Prevention

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9489052/

Time-restricted Eating to Address Cancer-related Fatigue ...

A 10-h TRE intervention was feasible and safe among survivors, and fatigue improved with a moderate effect size after two weeks.

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researchgate.net/publication/390526547_Time-restricted_eating_to_address_persistent_cancer-related_fatigue_among_cancer_survivors_a_randomized_controlled_trial

Time-restricted eating to address persistent cancer-related ...

In a randomized controlled trial, we tested the effects of TRE vs. control on fatigue in cancer survivorship. Methods Adult cancer survivors ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT05259410

Time Restricted Eating During Chemotherapy for Breast ...

Pre-clinical murine studies report intermittent fasting increases effectiveness of chemotherapy and decreases treatment related adverse events. The proposed ...