Time restricted eating during chemotherapy for breast cancer

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

This research investigates the effects of time restricted eating (TRE) combined with a Mediterranean diet on women undergoing chemotherapy for breast cancer. The study aims to determine if TRE can improve treatment-related outcomes, reduce side effects, and limit weight gain compared to standard care. By focusing on a daily eating window without calorie counting, the approach seeks to enhance adherence and patient quality of life while potentially improving clinical outcomes. The study will include women aged 25-99 with histologically confirmed Stage I-III breast cancer and adequate organ function.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 25-99 at time of consent
* ECOG 0 or 1
* Breast cancer to meet histologically confirmed Stage I-III.
* Demonstrates adequate organ function (absolutely 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 metastatic disease or type 1 or 2 diabetes
* Women with BMI ≥ 40kg/m2 and \< 25kg/m2
* Women who are pregnant. A negative serum or urine pregnancy test is required per institutional practice guidelines.
* Night 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)
* Active infection requiring systemic therapy
* Uncontrolled HIV/AIDS or active viral hepatitis
* Pregnant or nursing
* Any prior 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.
* 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 or excessive use of alcohol (i.e., \> 2 drinks/day)
* Currently participating in Weight Watcher's or another weight loss program
* Myocardial infarction
* Stroke
* Congestive heart failure
* Chronic hepatitis
* Cirrhosis
* Chronic pancreatitis
* History of solid organ transplantation

Where it's running

• University of Illinois Chicago
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Kelsey Gabel, MS, RD, PhD — Uic
• Study coordinator: Kelsey Gabel, 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.