Time-Restricted Eating for Cancer

Overseen By Nathalie Nguyen, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

Disqualifiers: Second malignancy, Uncontrolled CHF, Neuropathy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

175 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how meal timing might improve side effects from cancer treatments, affect tumor behavior, and change a person's mood and habits. Participants will follow either a time-restricted eating schedule (eating within an 8-hour window starting 1-3 hours after waking) or a regular eating schedule (eating over at least 12 hours). It suits those with rectal or specific types of breast cancer who are undergoing certain treatments and can adhere to a specific eating plan. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance cancer treatment experiences.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research shows that time-restricted eating (TRE) involves consuming all meals within a specific number of hours each day. Some studies have examined its health effects. One study found that individuals who ate all their food in less than 8 hours faced a higher risk of dying from heart problems. However, these results might not apply universally, and further research is needed for better understanding.

Other studies suggest that intermittent fasting, similar to TRE, might offer health benefits. These studies have shown mixed results, indicating that outcomes can vary among individuals.

TRE is not a new concept, and many have tried it without major issues. However, like any change in eating habits, it's important to monitor how the body reacts. Those considering joining a study should consult a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about time-restricted eating (TRE) for cancer patients because it offers a novel approach to dietary management with potential health benefits. Unlike traditional cancer treatments that often rely on drugs or surgery, TRE focuses on limiting food intake to an 8-hour window each day. This method could help improve metabolism and reduce inflammation, which might positively impact cancer progression. Additionally, TRE is a lifestyle intervention that doesn't involve medication, making it a potentially safer and more accessible option for patients.

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

This trial will compare Time-Restricted Eating (TRE) with a control group. Research has shown that TRE might reduce the risk of cancer recurrence. Studies have found that women who ate for less than 13 hours at night had a higher risk of breast cancer returning. Another study suggested that fasting could enhance chemotherapy's effectiveness and reduce its side effects. However, evidence also indicates that consuming all meals within an 8-hour period might increase the risk of heart-related mortality. Therefore, while TRE may offer cancer-related benefits, it is important to consider the potential risks as well. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for adults aged 21+ with stage II or III rectal cancer who plan to receive specific chemotherapy and radiation treatments. They must have a BMI of at least 18.5, be able to follow the study's schedule, and have good organ function. Excluded are those with recent cancers or treatments, certain health conditions like uncontrolled hypertension, active second malignancies (except some skin cancers), severe allergies to treatment agents, unstable psychiatric disorders, or women who are pregnant/breastfeeding.

Inclusion Criteria

Willing and able to adhere to the assessments, visit schedules, prohibitions, and restrictions

My organs and bone marrow are functioning well.

My rectal cancer is confirmed to be stage II or III.

Exclusion Criteria

I have a condition that affects my stomach or intestines, like constant vomiting or diarrhea.

You usually eat all your meals within 11 hours or less every day.

I have ongoing symptoms from a bowel disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo time-restricted eating (TRE) or control eating period alongside cancer treatment

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Control
• Time-Restricted Eating (TRE)

Trial Overview The study examines if time-restricted eating (TRE) can improve side effects from cancer treatment, affect tumor biology and change mood/behavior in patients with colorectal cancer. Participants will either follow TRE guidelines or continue their normal diet (control group) while undergoing standard cancer therapies.

How Is the Trial Designed?

Group I: Time-Restricted Eating (TRE) Experimental Treatment 1 Intervention

8-hour daily eating period, starting 1-3 hours after waking up

Group II: Control Active Control 1 Intervention

More than equal to a 12-hour daily eating period

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

Intermittent fasting can lower glucose levels in tumors, making them more responsive to the cancer drug metformin.

The study shows that using intermittent fasting before metformin treatment not only sensitizes resistant tumor cells but also significantly reduces tumor growth, suggesting a potential new strategy for cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teaching an Old Drug New Tricks. Momcilovic, M., Shackelford, DB.[2020]

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]

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 a 6-month randomized clinical trial with 75 participants who had type 2 diabetes, time-restricted eating (TRE) led to a significant weight loss of 3.56% compared to controls, while daily calorie restriction (CR) did not show a significant difference in weight loss.

Both TRE and CR resulted in similar reductions in hemoglobin A1c (HbA1c) levels, indicating that TRE can be an effective dietary strategy for improving glycemic control without the need for calorie counting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Time-Restricted Eating on Weight Loss in Adults With Type 2 Diabetes: A Randomized Clinical Trial. Pavlou, V., Cienfuegos, S., Lin, S., et al.[2023]

Preliminary findings indicate that combining intermittent fasting or a fasting-mimicking diet with endocrine therapy may enhance the effectiveness of treatment for hormone receptor-positive breast cancer.

This combination approach could also help in reducing side effects associated with the endocrine therapy, suggesting a potential strategy for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fasting May Complement Endocrine Therapy. [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]

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]

Periodic fasting enhances the effectiveness of endocrine treatments for hormone receptor-positive breast cancer by increasing their anti-cancer activity.

Fasting may help delay the development of resistance to these treatments by lowering levels of blood leptin, insulin, and insulin-like growth factor 1 (IGF1), suggesting a potential new strategy for improving breast cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing endocrine therapy activity via fasting cycles: biological rationale and clinical feasibility. Caffa, I., Nencioni, A.[2021]

Daily caloric restriction (CR) offers more effective protection against tumor growth and lung metastasis in a breast cancer model compared to periodic caloric cycling with a fasting-mimicking diet (FMD).

The enhanced cancer protection from daily CR may be linked to a distinct immune response that is not replicated by the FMD, suggesting that the consistency of dietary restriction plays a crucial role in cancer prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daily caloric restriction limits tumor growth more effectively than caloric cycling regardless of dietary composition. Pomatto-Watson, LCD., Bodogai, M., Bosompra, O., et al.[2023]

Time-restricted eating (TRE) can lead to a weight loss of 1-4% over 1-16 weeks in individuals with obesity, primarily due to unintentional reductions in daily calorie intake of about 350-500 kcal.

TRE is effective in improving cardiovascular health by lowering fat mass, blood pressure, triglyceride levels, and markers of oxidative stress, and it is considered safe with few adverse events reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-Restricted Eating to Improve Cardiovascular Health. Gabel, K., Cienfuegos, S., Kalam, F., et al.[2021]

In a pilot study of 50 participants with obesity over 12 weeks, time-restricted eating (TRE) led to a modest average weight loss of 2.6 kg, with greater weight loss observed in those who adhered to the regimen at least five days a week.

While TRE showed similar weight loss results compared to more complex weight management methods, it did not significantly impact blood pressure or lipid profiles, suggesting its primary benefit may be in weight management rather than metabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time restricted eating as a weight loss intervention in adults with obesity. Przulj, D., Ladmore, D., Smith, KM., et al.[2021]

In an 8-week pilot study involving 78 participants with obesity, those following a 14-hour time-restricted eating (TRE) schedule lost an average of 8.5% of their body weight, which was statistically significant compared to a 12-hour TRE group that lost 7.1%.

The 14:10 TRE group also experienced a significant reduction in fasting blood glucose levels by 7.6 mg/dl, indicating potential metabolic benefits, especially for those with elevated blood glucose at baseline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of time restricted eating on body weight and fasting glucose in participants with obesity: results of a randomized, controlled, virtual clinical trial. Peeke, PM., Greenway, FL., Billes, SK., et al.[2021]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12229459/

Time-restricted eating and cancer: lessons learned ... In addition to improved HbA1c, prolonged nightly fasting was associated with a statistically significant lower risk of disease recurrence in a cohort of breast ...

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

Clinical Impact of Time-restricted Eating on Cancer Specifically, women who fasted for less than 13 hours per night were at increased risk of breast cancer recurrence compared with women who ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05722288

NCT05722288 | Time-Restricted Eating Versus Nutritional ... This phase II trial studies how well time-restricted eating works in reducing side effects of radiation or chemoradiation side effects when compared to ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2161831322000837

Current Evidence and Directions for Intermittent Fasting ... Available data show that periodic fasting, a form of intermittent fasting, may hold potential to improve the effectiveness of chemotherapy, decrease treatment- ...

5. newsroom.heart.org newsroom.heart.org/news/8-hour-time-restricted-eating-linked-to-a-91-higher-risk-of-cardiovascular-death

8-hour time-restricted eating linked to a 91% higher risk of ... People who followed a pattern of eating all of their food across less than 8 hours per day had a 91% higher risk of death due to cardiovascular ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04722341?term=NCT04722341

Time-Restricted Eating and Cancer: Clinical Outcomes ... The purpose of this study is to test whether the timing of meals can improve treatment adverse events, influence tumor biology and alter a person's mood and ...

7. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-53702400098-1/fulltext

Intermittent fasting and health outcomes: an umbrella ... Benefits of Intermittent fasting (IF) on health-related outcomes have been found in a range of randomised controlled trials (RCTs).