NCT04722341Completed
Time-Restricted Eating and Cancer: Clinical Outcomes, Mechanisms, and Moderators
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 98 (actual)
- First submitted
- 14 Dec 2020
- Start date
- 1 Jan 2022
- Primary completion date
- 31 Jul 2026
- Lead sponsor
- Cedars-Sinai Medical Center
- Diseases
- Colorectal cancer
- NCT number
- NCT04722341
What you commit to
- Study type: Interventional
- Participants enrolled: 98
- From 1 Jan 2022 to the primary completion date, 31 Jul 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of cytotoxic chemotherapy less than or equal to 12 months prior to rectal or breast cancer diagnosis
- Any prior pelvic radiotherapy
- History of GI perforation ≤12 months prior to enrollment
- Receiving any parenteral nutrition or enteral (tube) feeding or using similar nutritional supplement during the study period
- Currently participating in or has participated in a study of an investigational agent or investigational device ≤4 weeks of the first dose of treatment
Other illness
- Allergic reaction to any of the treatment agents
- Currently active second malignancy other than non-melanoma skin cancers or cervical carcinoma in situ
- History of predisposing colonic or small bowel disorders with severe or rapidly worsening symptoms (not related to current cancer symptoms)
- History of uncontrolled congestive heart failure defined as ew York Heart Association Class (NYHA) Class III or greater
- Known psychiatric or substance abuse disorders that would interfere with adhering to the requirements of the trial
Lab values
- Medical condition or laboratory abnormality that could impact participant safety or data validity, in the opinion of the medical investigators.
Other
- Pre-existing grade ≥3 neuropathy
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Cedars Sinai Medical Center Coordinator of this site? Confirm its status | West Hollywood | United States | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.