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RecruitingNot ApplicableNCT04722341

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

Sponsor

Cedars-Sinai Medical Center

Enrollment

175 participants

Start Date

Jan 1, 2022

Study Type

INTERVENTIONAL

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • 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 Criteria15

  • 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.

Interventions

BEHAVIORALTime-Restricted Eating (TRE)

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

BEHAVIORALControl

More than equal to a 12-hour daily eating period

Locations(2)

The University of Alabama at Birmingham

Birmingham, Alabama, United States

Cedars-Sinai Medical Center

West Hollywood, California, United States

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NCT04722341