Time-Restricted Eating and Cancer: Clinical Outcomes, Mechanisms, and Moderators

December 11, 2025 updated by: Sarah Salvy, Cedars-Sinai Medical Center
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 behaviors.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Combining fasting with chemotherapy is known to cause complete tumor regression and long-term survival in animal models. According to the Differential Stress Sensitization (DSS) theory, acute fasting sensitizes tumor cells to the cytotoxic effects of chemotherapy and radiation, while protecting healthy cells by increasing stress resistance. These effects are believed to be largely mediated via the Insulin-like Growth Factor (IGF-1) pathway. However, extended fasting can be challenging for patients and poses undue health risks. A number of alternative intermittent fasting regimens have been proposed to overcome the challenges of prolonged caloric restriction. One promising approach is time-restricted eating (TRE), which involves eating within a period of 10 hours or less, followed by fasting for at least 14 hours daily. TRE does not involve extended caloric restriction, and because of its simplicity, it may be more sustainable than other fasting regimens. TRE improves several cardiometabolic endpoints independent of calorie restriction in both animals and humans, including insulin sensitivity, blood pressure, fat oxidation, and hunger. Our team's pilot and feasibility trials suggest that TRE may also have anti-cancer effects: it decreases IGF-1 levels, reduces oxidative stress, upregulates antioxidant defenses, and enhances autophagy. Moreover, our data suggest TRE is sustainable, as participants were adherent 6.0 plus or minus 0.8 days/week over a 14-week period. These findings lead to the following provocative question: Can TRE reduce treatment-related toxicity, induce tumor regression, and improve both patient-reported and clinical outcomes? We propose to conduct the largest randomized controlled trial of any form of intermittent fasting in patients undergoing cancer treatment. We focus on patients with localized rectal or breast cancer because it is one of the few treatment paradigms in which tumor characteristics can be measured before and after chemoradiation therapy.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
175

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • The University of Alabama at Birmingham
        • Contact:
          • Courtney M Peterson, PhD
        • Principal Investigator:
          • Courtney M Peterson, PhD
    • California
      • West Hollywood, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Medical Center
        • Contact:
          • Nathalie Nguyen, MPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Any sex/gender of any ethnic/racial background
  • Age greater than or equal to 18 years
  • Histologically-confirmed rectal cancer stage II, III, or IV (if curative) or human epidermal growth factor receptor 2-positive (HER2+) or triple negative breast cancer stage I, II, or III (only if definitive intent) per American Joint Committee on Cancer (AJCC) criteria
  • BMI 18.5 kg/m2 or greater
  • Receiving either neoadjuvant therapy with curative intent (breast cancer patients) or total neoadjuvant therapy with a 5-fluorouracil-based regimen and curative intent (rectal cancer patients)
  • Has completed ≤ 4 weeks of neoadjuvant treatment prior to study enrollment
  • Willing and able to adhere to the assessments, visit schedules, prohibitions, and restrictions

Exclusion Criteria:

  • History of cytotoxic chemotherapy less than or equal to 12 months prior to rectal or breast cancer diagnosis
  • Allergic reaction to any of the treatment agents
  • Any prior pelvic radiotherapy
  • Currently active second malignancy other than non-melanoma skin cancers or cervical carcinoma in situ
  • History of GI perforation ≤12 months prior to enrollment
  • History of predisposing colonic or small bowel disorders with severe or rapidly worsening symptoms (not related to current cancer symptoms)
  • Receiving any parenteral nutrition or enteral (tube) feeding or using similar nutritional supplement during the study period
  • History of uncontrolled congestive heart failure defined as ew York Heart Association Class (NYHA) Class III or greater
  • Pre-existing grade ≥3 neuropathy
  • Currently participating in or has participated in a study of an investigational agent or investigational device ≤4 weeks of the first dose of treatment
  • Pregnant or breastfeeding
  • Currently perform overnight shift work more than one day/week on average
  • Strictly adhering to a <10-hour eating window on most days
  • Known psychiatric or substance abuse disorders that would interfere with adhering to the requirements of the trial
  • Medical condition or laboratory abnormality that could impact participant safety or data validity, in the opinion of the medical investigators.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control
More than equal to a 12-hour daily eating period
Behavioral: Control
More than equal to a 12-hour daily eating period
Experimental: Time-Restricted Eating (TRE)
8-hour daily eating period. Participants eating window must start within 2 hours of waking up and no later than 9 am.
Behavioral: Time-Restricted Eating (TRE)
8-hour daily eating period, starting 1-3 hours after waking up

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pathologic Complete Response (pCR) and Organ Preservation Rate
Time Frame: at end of 6-month intervention
Measures whether participants achieve either a pathologic complete response (no invasive cancer is found in the removed tumor or sampled lymph nodes) or organ preservation at the end of treatment. For rectal cancer, organ preservation is defined as a complete or near-complete clinical response after therapy that allows the patient to safely avoid surgery, based on findings from exam, endoscopy, and MRI. Quantified as a percentage (%).
at end of 6-month intervention
Patient-Reported AEs (PRO-CTCAEs)
Time Frame: at end of 6-month intervention
Adverse events as measured by the PRO-CTCAE (version 5), which includes about three dozen toxicities that patients can systematically document the frequency, severity (and interference of each toxicity).
at end of 6-month intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical Response
Time Frame: at end of 6-month intervention
Clinical response at end of treatment, categorized as: complete (no detectable disease on exam, endoscopy, or MRI); near-complete (minimal residual abnormality); partial (≥30% tumor decrease); stable disease; or progressive disease (≥20% tumor increase). We will also report the objective response rate (complete + near-complete + partial), percent with complete/near-complete responses, and percent with progressive disease. For breast cancer, responses may be estimated by physicians or MRI technicians. Values will also be expressed as percentages.
at end of 6-month intervention
Tumor Response
Time Frame: at end of 6 month intervention
Different scales by cancer type. Rectal cancer, using MRI Tumor Regression Grade (1-5, with 1 = complete response) at end of treatment and the Neoadjuvant Rectal (NAR) score (0-100) at baseline and post-intervention. Breast cancer measured using the Residual Cancer Burden (RCB) score (0-4), where 0 indicates a pathologic complete response.
at end of 6 month intervention
Provider-Reported AEs (Treatment Related Toxicities)
Time Frame: at end of 6 month intervention
Measures treatment-related adverse events (AEs) reported by providers from the start of therapy to the day before surgery. AEs are graded using CTCAE v5, and we will report totals as well as Grade 1-2 and Grade 3-4 events. The Toxicity Index (TI) will also be calculated, which ranges from 0 to 5.83.
at end of 6 month intervention
Health-Related Quality of Life
Time Frame: at end of 6 month intervention
Assessed at each testing visit using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core 30 (EORTC QLQ-C30) for all participants, the QLQ-breast cancer 23 (QLQ-BR32) for breast cancer, and the QLQ-rectal cancer 29 (QLQ-CR29) for rectal cancer. All scales are scored from 0-100, with higher functional and global health scores indicating better quality of life and higher symptom scores indicating worse symptoms. The QLQ-C30 includes five functional scales, three symptom scales, and a global quality-of-life scale, while the BR23 and CR29 include cancer-specific functional and symptom scales.
at end of 6 month intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Complete Blood Counts (CBCs)
Time Frame: at end of 6 month intervention
Obtained through each site's hospital laboratory; results from within two weeks of a testing visit may be used instead of a new draw. All CBC values collected from consent to surgery will be included in analyses. For rectal cancer patients, Carcinoembryonic Antigen (CEA) and Carbohydrate Antigen 19-9 (CA 19-9) results from consent to surgery will also be extracted from the medical record.
at end of 6 month intervention
Protein Expression Related to Cell Growth and Death
Time Frame: at end of 6 month intervention
Measure molecular markers representing cell growth and death and stress resistance, including Antigen Kiel 67 (Ki-67; cell proliferation), caspase 3 (apoptosis), microtubule-associated protein light chain 3B (LC3-I/LC3-II; autophagy), and phosphorylated histone H2AX (γ-H2AX; DNA damage). Protein expression will be measured in formalin-fixed paraffin-embedded tumor and adjacent normal tissue obtained from both biopsy (baseline) and surgical resection (post-intervention). Values will be expressed as fold changes.
at end of 6 month intervention
Total Antioxidant Capacity
Time Frame: at end of 6 month intervention
Measured in serum and/or peripheral blood mononuclear cells (PBMCs) collected at each testing visit. PBMCs isolated from whole blood. Values expressed in A.U.
at end of 6 month intervention
Body weight
Time Frame: at end of 6 month intervention
Measured at each in-person visit after ≥8 hours of fasting, using a calibrated metabolic scale. Interim non-fasting weights will be extracted from the medical record when available. Weight will be recorded in kilograms to the nearest 0.1 kg.
at end of 6 month intervention
Blood pressure
Time Frame: at end of 6 month intervention
Systolic and diastolic blood pressure will be measured using an automated blood pressure monitor following American Heart Association/American College of Cardiology guidelines. After a five-minute seated rest, three readings will be taken 1-2 minutes apart; the average of the two closest values will be used. If blood pressure cannot be collected at a testing visit, values from the nearest clinical encounter will be extracted from the medical record. Blood pressure is reported in mm Hg.
at end of 6 month intervention
Heart Rate
Time Frame: at end of 6 month intervention
Measured concurrently with blood pressure using the automated monitor. Three readings will be obtained after a five-minute rest, and the average of the two closest measurements will be used. Heart rate is recorded in beats per minute (bpm).
at end of 6 month intervention
Adherence
Time Frame: at end of 6 month intervention
Self-reported in weekly surveys, with participants recording daily eating start/stop times and reasons for non-adherence using surveys. Quantified as the percentage of adherent days (eating window followed within 30 minutes; missing days counted as non-adherent) and the median eating duration.
at end of 6 month intervention
Fatigue
Time Frame: at end of 6 month study
Measured using the Patient-Reported Outcomes Measurement Information System (PROMIS®) Fatigue subscale. Items are rated on a Likert scale and converted to T-scores (mean = 50, standard deviation (SD) = 10), with higher scores indicating greater fatigue.
at end of 6 month study
Social Functioning
Time Frame: at end of 6 month study

Measured using:

  • University of California at Los Angeles (UCLA) 3-Item Loneliness Scale: scores range from 3-9, with higher scores indicating greater loneliness.
  • PROMIS® Satisfaction with Participation in Discretionary Social Activities (Short Form 7a): Likert-scale items converted to T-scores (mean = 50, SD = 10), with higher scores indicating greater social satisfaction.
at end of 6 month study
Physical Functioning
Time Frame: at end of 6 month study
Assessed using the PROMIS® Physical Function subscale (Likert-scale items). Scores are converted to T-scores (mean = 50, SD = 10), with higher scores indicating better physical function.
at end of 6 month study
Mood
Time Frame: at end of 6 month study
Assessed using the PROMIS® Anxiety subscale. Responses are scored on Likert-scale items and converted to age-standardized T-scores (mean = 50, SD = 10), with higher scores indicating greater anxiety.
at end of 6 month study
Dietary Intake
Time Frame: at end of 6 month intervention
Assessed using three-day food records (two weekdays and one weekend day) in conjunction with each testing visit. Measures will include total energy intake, Healthy Eating Index (HEI-2015) scores, and intake of key dietary components such as added sugar, fruits and vegetables, solid fats, alcohol, sodium, and fats.
at end of 6 month intervention
Appetite
Time Frame: at end of 6 month intervention
Assessed using two self-report scales: (1) a retrospective 5-point Likert scale rating the frequency of hunger and fullness over the past week, and (2) a 100-point visual analog scale (0 = "Not at all," 100 = "Extremely") rating typical hunger and fullness levels during eating and fasting windows.
at end of 6 month intervention
Eating Behavior
Time Frame: at end of 6 month intervention
Assessed using the Dutch Eating Behavior Questionnaire (DEBQ), which measures three domains: emotional eating, external eating, and restrained eating. Scores reflect the frequency of behaviors within each domain, with higher scores indicating greater endorsement of that eating pattern.
at end of 6 month intervention
Physical Activity
Time Frame: at end of 6 month intervention
Assessed using an ActiGraph GT9X accelerometer. Activity outcomes derived using GGIR algorithms, including metabolic equivalents (METs) and the percentage of time spent in sedentary, light, moderate, and vigorous activity (Friedson algorithms). Self-reported physical activity measured using the General Physical Activity Questionnaire (GPAQ), MET-minutes per week for moderate and vigorous activity and estimates daily sedentary time.
at end of 6 month intervention
Sleep
Time Frame: at end of 6 month intervention
Measured using accelerometer-derived estimates from the ActiGraph GT9X (processed with GGIR) for sleep duration, timing, and sleep efficiency. Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI; global score 0-21, with higher scores indicating poorer sleep), and sleep duration and timing will be self-reported using the Munich Chronotype Questionnaire (MCTQ). Values for the latter will be reported in either minutes or hours.
at end of 6 month intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cedars-Sinai Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)
University of Alabama at Birmingham
Harvard University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 14, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 25, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 15494
  • 1R01CA258222-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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