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

NCT04722341 | Recruiting

• 2 other identifiers: 154941R01CA258222-01
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 2

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

Breast Cancer; Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

• Pathologic Complete Response (pCR) and Organ Preservation Rate

  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)

  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 Outcomes (4)

• Clinical Response

  at end of 6-month intervention

• Tumor Response

  at end of 6 month intervention

• Provider-Reported AEs (Treatment Related Toxicities)

  at end of 6 month intervention

• Health-Related Quality of Life

  at end of 6 month intervention

Other Outcomes (16)

• Complete Blood Counts (CBCs)

  at end of 6 month intervention

• Protein Expression Related to Cell Growth and Death

  at end of 6 month intervention

• Total Antioxidant Capacity

  at end of 6 month intervention

Study Arms (2)

Time-Restricted Eating (TRE)

EXPERIMENTAL

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)

Control

ACTIVE COMPARATOR

More than equal to a 12-hour daily eating period

Behavioral: Control

Interventions

Time-Restricted Eating (TRE) BEHAVIORAL

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

Time-Restricted Eating (TRE)

Control BEHAVIORAL

More than equal to a 12-hour daily eating period

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• National Cancer Institute (NCI): collaborator
• University of Alabama at Birmingham: collaborator
• Harvard University: collaborator

Study Sites (2)

The University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

Cedars-Sinai Medical Center

West Hollywood, California, 90048, United States

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Nathalie Nguyen, MPH

CONTACT

310.423.4209; nathalie.nguyen@cshs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: January 25, 2021
• Study Start: January 1, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-04

Locations

US (2)