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

  • STATUS
    Recruiting
  • End date
    Dec 14, 2026
  • participants needed
    300
  • sponsor
    Cedars-Sinai Medical Center
Updated on 14 May 2022

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.

Details
Condition Colo-rectal Cancer
Treatment Control, Time-Restricted Eating (TRE)
Clinical Study IdentifierNCT04722341
SponsorCedars-Sinai Medical Center
Last Modified on14 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female of any ethnic/racial background
Age 21 years or older
Histologically confirmed rectal cancer stage II or III per AJCC criteria
BMI 18.5 kg/m2 or greater
Plan to receive either neoadjuvant conventional chemoradiation or total neoadjuvant therapy (TNT) with 5-fluorouracil-based regimens
Demonstrate adequate organ and marrow function within two weeks of study treatment initiation
Willing and able to adhere to the assessments, visit schedules, prohibitions, and restrictions

Exclusion Criteria

Prior neoadjuvant or adjuvant chemotherapy/radiation <12 months prior to rectal cancer occurrence
Allergic reaction to any of the treatment agents
Any prior pelvic radiotherapy or chemoradiotherapy
Major surgery/open biopsy ≤4 weeks prior to enrollment or minor surgery/core biopsy ≤1 week prior to enrollment
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 malabsorption, uncontrolled vomiting or diarrhea, or other GI-function affecting disease
History of predisposing colonic or small bowel disorders with uncontrolled symptoms
Receiving any parenteral nutrition or enteral (tube) feeding or using any other nutritional supplement during the study period
History of uncontrolled CHF defined as NYHA Class III or greater
Uncontrolled hypertension
History of bleeding events, bleeding diathesis, arterial thrombotic events (including TIA, CVA, unstable angina requiring intervention, or MI), or clinically significant PAD and ≤6 months prior to enrollment
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
Unstable psychiatric, sleep, or circadian conditions (common conditions such as sleep apnea and depression are acceptable as long as they are stabilized and not rapidly worsening)
Pregnant or breastfeeding
Currently perform overnight shift work more than one day/week on average
Regularly eat within an <11-hour period each day
Will travel more than three time zones away during the study
Known psychiatric or substance abuse disorders that would interfere with adhering to the requirements of the trial
History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation in the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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