Time-Restricted Eating for Cancer Treatment
Time-Restricted Eating and Cancer: Clinical Outcomes, Mechanisms, and Moderators
This study is testing if eating only during a 10-hour window can help improve the results of chemotherapy for people with colorectal and breast cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 175 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cedars-Sinai Medical Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Birmingham, Alabama and 1 other locations) |
| Trial ID | NCT04722341 on ClinicalTrials.gov |
What this trial studies
This study investigates whether time-restricted eating (TRE) can enhance the effectiveness of chemotherapy and improve patient outcomes in individuals with colorectal and breast cancer. By limiting the eating window to 10 hours or less, the study aims to leverage the benefits of fasting without the risks associated with prolonged caloric restriction. The research will assess the impact of TRE on treatment-related adverse events, tumor biology, and patient mood and behaviors, building on previous findings that suggest TRE may have anti-cancer effects. Participants will be monitored for adherence to the eating regimen and its effects on various health markers.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with specific stages of colorectal or breast cancer who are about to begin neoadjuvant therapy.
Not a fit: Patients with a history of recent chemotherapy, certain allergies, or active second malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes and quality of life for cancer patients undergoing chemotherapy.
How similar studies have performed: Previous studies have shown promising results with fasting and intermittent fasting approaches, suggesting potential for success with this novel application of time-restricted eating.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Birmingham, Alabama and 1 other locations
- The University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
- Cedars-Sinai Medical Center — West Hollywood, California, United States (Recruiting)
Study contacts
- Study coordinator: Nathalie Nguyen, MPH
- Email: nathalie.nguyen@cshs.org
- Phone: 310.423.4209
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.