Meal timing may ease cancer therapy woes
NCT ID NCT04722341
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether eating only during certain hours of the day can reduce side effects from cancer treatment and improve mood and behavior. About 175 adults with colorectal or breast cancer will follow a time-restricted eating plan while receiving standard therapy. Researchers will track tumor response and patient-reported side effects to see if meal timing makes a difference.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 175 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2022
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cedars-Sinai Medical Center
RECRUITINGWest Hollywood, California, 90048, United States
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The University of Alabama at Birmingham
RECRUITINGBirmingham, Alabama, 35294, United States
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