Time‑restricted eating (8‑hour window) during chemotherapy for breast cancer: feasibility and acceptability

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants starting chemotherapy will be assigned to one of three 8‑hour time‑restricted eating schedules or to a usual‑care control group and followed for 24 weeks to measure adherence and acceptability. The trial will collect patient‑reported outcomes, side effect profiles, and basic clinical and laboratory measures to track safety and feasibility. Time‑restricted eating requires no calorie counting and aims to limit weight and body‑fat gain while potentially improving glucose regulation during treatment. The study is conducted at Chicago sites affiliated with the University of Illinois Chicago and the Robert H. Lurie Comprehensive Cancer Center.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 25-99 at time of consent
* English language or Spanish language (based on availability of lab interpreters)
* ECOG 0 or 1
* Breast cancer to meet histologically confirmed Stage I-III or Stage IV with Medical Oncology approval.
* Demonstrates adequate organ function (absolute neutrophil count ≥ 1,500/μL).
* All screening labs to be obtained within 30 days prior to registration.
* Able to provide written informed consent and HIPAA authorization for release of personal health information, via an approved UIC Institutional Review Board (IRB) informed consent form and HIPAA authorization.
* Women of childbearing potential must not be pregnant or breast-feeding. A negative serum or urine pregnancy test is required per institutional practice guidelines.
* As determined at the discretion of the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.

Exclusion Criteria:

* Women with type 1 or insulin dependent type 2 diabetes
* Women with BMI \> 45kg/m2 and \< 18.5 kg/m2
* Women who are pregnant or nursing. A negative serum or urine pregnancy test is required per institutional practice guidelines.
* Shift workers
* Women with a history of eating disorders
* Enrolled participants with a significant weight loss or weight gain within 3 months of the study (weight gain or loss \>4kg)
* Uncontrolled HIV/AIDS or active viral hepatitis
* Any prior malignancy \<5 years, chemotherapy within the last year or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this investigational regimen, as determined by the treating medical oncologist.
* Breast cancer recurrence classified by the treating medical oncologist
* Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial.
* Other major comorbidity, as determined by study PI
* Illicit drug use within previous 3 months or excessive use of alcohol (i.e., \> 2 drinks/day)
* Currently participating in Weight Watcher's or another weight loss program, including weight loss medication such as GLP-1 medications.
* Myocardial infarction
* Congestive heart failure
* Chronic hepatitis
* Cirrhosis
* Chronic pancreatitis
* History of solid organ transplantation

Where it's running

• Robert H. Lurie Comprehensive Cancer Center
  Chicago, Illinois, United States Recruiting
• University of Illinois Chicago
  Chicago, Illinois, United States Recruiting

Study contacts

• Study coordinator: Kelsey Gabel, RD, PhD
• Email: kdipma2@uic.edu
• Phone: 312-413-8911

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.