RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-01-01

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04722341

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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) per AJCC criteria * Histologically confirmed breast cancer stage II, III, or IV (only if definitive intent) per AJCC criteria * BMI 18.5 kg/m2 or greater * Will receive total neoadjuvant therapy (TNT) * Willing and able to adhere to the assessments, visit schedules, prohibitions, and restrictions	* 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 CHF defined as 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

Inclusion Criteria

Exclusion 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) per AJCC criteria
* Histologically confirmed breast cancer stage II, III, or IV (only if definitive intent) per AJCC criteria
* BMI 18.5 kg/m2 or greater
* Will receive total neoadjuvant therapy (TNT)
* Willing and able to adhere to the assessments, visit schedules, prohibitions, and restrictions

* 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 CHF defined as 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

Contacts and Locations

Study Contact

Nathalie Nguyen, MPH

CONTACT

310.423.4209

nathalie.nguyen@cshs.org

Study Locations (Sites)

Cedars-Sinai Medical Center

West Hollywood, California, 90048

United States

Collaborators and Investigators

Sponsor: Cedars-Sinai Medical Center

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 Registration Dates

Study Start Date2022-01-01

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2022-01-01

Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

Colorectal Cancer
Breast Cancer