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Time-Restricted Eating for Colorectal and Breast Cancer

This study is exploring if changing when you eat, called Time-Restricted Eating (TRE), can help people with colorectal or breast cancer. TRE involves eating all your meals within an 8-hour window each day, starting 1-3 hours after waking up. The study wants to see if this eating pattern can reduce side effects from treatment, affect how tumors behave, and improve your mood and daily activities. You might be able to join if you are at least 18 years old and have stage II, III, or IV colorectal cancer, or HER2-positive (a type of breast cancer) or triple-negative breast cancer stage I, II, or III. Researchers will compare those doing TRE with a control group who eat over a 12-hour period or more. Success will be measured by how well the tumor responds (pathologic complete response) and how many organs are preserved, as well as patient-reported side effects after 6 months. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 175 participants, comparing Time-Restricted Eating to a control group.
What's involved
Participants will follow either an 8-hour daily eating period or a 12-hour or more daily eating period for 6 months.
Compensation
Not stated in the trial record.
Follow-up
Primary outcomes are measured at the end of the 6-month intervention period.

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NCT04722341

Time-Restricted Eating and Cancer: Clinical Outcomes, Mechanisms, and Moderators

Recruiting
NAAges 18+InterventionalTreatment
Cedars-Sinai Medical Center
~175 participants
Updated 2025-12-16 on ClinicalTrials.gov
What's tested:Time-Restricted Eating (TRE)Control

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pathologic Complete Response (pCR) and Organ Preservation Rate
Measured over at end of 6-month intervention
+1 more outcome measured

Conditions

Colorectal Cancer
Breast Cancer

Explore related trials

Breast CarcinomaRectal Carcinoma

Where it's being run

2 sites across 2 states
Alabama1
California1

Who to contact

Nathalie Nguyen, MPH
[email protected]
310.423.4209
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Pathologic Complete Response (pCR) and Organ Preservation Rateat 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)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).