Recruiting

Time-Restricted Eating

Sponsor:

Cedars-Sinai Medical Center

Code:

NCT04722341

Conditions

Colorectal Cancer

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Time-Restricted Eating (TRE)

Control

Study Details

Brief summary:

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.

Conditions

Colorectal Cancer

Breast Cancer

Study ID

NCT04722341

Start date

Jan 1, 2022

Status verified date

Apr, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

175 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

active comparator: Control

More than equal to a 12-hour daily eating period

Interventions

Time-Restricted Eating (TRE)

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

Control

More than equal to a 12-hour daily eating period

Primary outcome measure

  • Pathologic Complete Response (pCR) and Organ Preservation Rate [ Time Frame: at end of 6-month intervention ]
  • Patient-Reported AEs (PRO-CTCAEs) [ Time Frame: at end of 6-month intervention ]

Central Contacts and Locations

Central contacts

Nathalie Nguyen, MPH

310.423.4209nathalie.nguyen@cshs.org

Locations

The University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Principal Investigator:

Courtney M Peterson, PhD

Cedars-Sinai Medical Center

Recruiting

West Hollywood, California, United States, 90048

More Information

Sponsor

Cedars-Sinai Medical Center

Last update posted

Dec 16, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cedars-Sinai Medical Center on 2025-12-16.