Time-Restricted Eating and Cancer: Clinical Outcomes, Mechanisms, and Moderators
Recruiting now · Not applicable
Conditions studied: Colorectal Cancer, Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT04722341
- Run by
- Cedars-Sinai Medical Center
- People needed
- 175
- Starts
- 2022-01-01
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2025-12-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- The University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
- Cedars-Sinai Medical Center — West Hollywood, California, United States (enrolling)
Full record on ClinicalTrials.gov
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