Clinical trial · Interventional
Time-Restricted Eating and Cancer: Clinical Outcomes, Mechanisms, and Moderators
NCT04722341CI-TRIAL-00099039recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control | Behavioral | — | UNRESOLVED |
| Time-Restricted Eating (TRE) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Time-Restricted Eating (TRE)
- description
- 8-hour daily eating period. Participants eating window must start within 2 hours of waking up and no later than 9 am.
- interventionNames
- Behavioral: Time-Restricted Eating (TRE)
- type
- ACTIVE_COMPARATOR
- label
- Control
- description
- More than equal to a 12-hour daily eating period
- interventionNames
- Behavioral: Control
Primary outcomes (2)
- measure
- Pathologic Complete Response (pCR) and Organ Preservation Rate
- timeFrame
- at end of 6-month intervention
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion 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) 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 Criteria: * 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.
References
Publications (1)
- DERIVEDSalvy SJ, Figueiredo JC, Atkins KM, Hollis RH, Jahan N, Gunnells DJ, Sleight AG, Gresham G, Diniz MA, Richman JS, Gong J, Zaghiyan K, Heslin MJ, Lee KJ, Sarfraz H, Peterson CM. The CHRONO trial: Protocol for a randomized controlled trial of early time-restricted eating in patients with breast or rectal cancer. Nutr Res. 2026 Jul;151:77-94. doi: 10.1016/j.nutres.2026.04.016. Epub 2026 May 2. PMID 42190452