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Time Restricted Eating During Chemotherapy for Breast Cancer

This study is looking at whether time restricted eating (eating all your food within an 8-hour window each day) is practical and acceptable for people receiving chemotherapy for early-stage breast cancer (stages 1-3). Researchers want to see if this eating pattern can help people going through treatment. You would choose an 8-hour eating window (starting at 10 AM, 11 AM, or 12 PM) and fast for the remaining 16 hours daily, without calorie or food restrictions. The study aims to enroll 40 women, aged 25 to 99, who have early-stage breast cancer and meet certain health criteria. The main goals are to see how many people join, how well they like time restricted eating, and how consistently they follow it over 24 weeks.

Study design
This interventional study plans to enroll 40 participants. It will compare three different time restricted eating window options to a control group.
What's involved
Participants assigned to time restricted eating will follow an 8-hour eating window and 16-hour fasting period daily for 24 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints for this study are measured at 24 weeks.

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NCT07387445

Feasibility and Acceptibility of a Multi-site Trial of Time Restircted Eating During Chemotheraply for Breast Cancer.

Recruiting
NAAges 25–99InterventionalTreatment
University of Illinois at Chicago
~40 participants
Updated 2026-05-01 on ClinicalTrials.gov
What's tested:Time restricted eating

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recruitment feasibility
Measured over 24 weeks
+2 more outcomes measured

Conditions

Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Breast Neoplasm Female
Breast Cancer

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Breast Carcinoma

Where it's being run

2 sites across 1 states
Illinois2

Who to contact

Kelsey Gabel, RD, PhD
[email protected]
312-413-8911
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Recruitment feasibility24 weeks

    women eligible and referred by staff to the research team. We will also track the number of referred women approached (by phone \& in person) by our research team for screening/enrollment and the number of women who decline and their reasons for non-enrollment

  • TRE Acceptibility24 weeks

    attendance at study visits, completeness of data, and overall and treatment specific loss to follow-up/withdrawal will be closely monitored

  • TRE adherence24 weeks

    Diet adherence will be monitored either by patient reported start and stop times of food intake and diet pattern scoring and will be assessed by the study coordinator with a total score of 7 days per week followed by a post intervention qualitative survey.