NCT04722341 · Cedars-Sinai Medical Center
Time-Restricted Eating and Cancer: Clinical Outcomes, Mechanisms, and Moderators
What this study is about
The purpose of this study is to test whether the timing of meals can improve treatment side effects, influence tumor biology and alter a person's mood and behaviors.
View original scientific description
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.
Interventions
BEHAVIORAL
Time-Restricted Eating (TRE)
8-hour daily eating period, starting 1-3 hours after waking up
BEHAVIORAL
Control
More than equal to a 12-hour daily eating period
Primary outcome measures
Pathologic Complete Response (pCR) and Organ Preservation Rate
Time frame: at end of 6-month intervention
Measures whether participants achieve either a pathologic complete response (no invasive cancer is found in the removed tumor or sampled lymph nodes) or organ preservation at the end of treatment. For rectal cancer, organ preservation is defined as a complete or near-complete clinical response after therapy that allows the patient to safely avoid surgery, based on findings from exam, endoscopy, and MRI. Quantified as a percentage (%).
Patient-Reported AEs (PRO-CTCAEs)
Time frame: at end of 6-month intervention
Adverse events as measured by the PRO-CTCAE (version 5), which includes about three dozen toxicities that patients can systematically document the frequency, severity (and interference of each toxicity).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Birmingham, Alabama
- West Hollywood, California
Collaborators
National Cancer Institute (NCI), University of Alabama at Birmingham, Harvard University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 16, 2025 · Source of record for eligibility and locations