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

April 27, 2026 updated by: Kelsey Nicole Dipman Gabel, University of Illinois at Chicago

Time Restricted Eating During Chemotherapy for Breast Cancer

This study is being done to better understand how time restricted eating (eating all food in an 8 hour window) can help a person receiving chemotherapy treatment for breast cancer, stages I-IV. The aim is to find out if time restricted is feasible and acceptable to individuals starting chemotherapy for breast cancer. We will test 3 different eating window options compared to a control group for 24 weeks.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Little is known about how nutrition therapy can affect breast cancer treatment outcomes. Current standard care suggests enough daily calories and protein to maintain body weight and avoid muscle loss. However, this approach may be antiquated given weight gain is common during treatment and emerging pre-clinical and clinical evidence suggest that fasting during chemotherapy may improve clinical and patient-reported outcomes. For example, preliminary human trials examining the fasting mimicking diet (very low-calorie, low-protein diet 1-week per month) or short-term fasting (48-120 hours (h)), known as periodic fasting, surrounding chemotherapy may increase effectiveness of treatment and decrease side effects related to chemotherapy. Yet these diets have low adherence, side effects of their own, and may increase patient burden and decrease quality of life. In contrast, time restricted eating (TRE) is a form of intermittent fasting with high adherence that may have similar positive effects on treatment outcomes without the untoward side-effects. Moreover, TRE may have beneficial effects on glucose regulation and body composition (i.e., decreased weight and body fat gain) suggesting the potential importance of this regimen to breast cancer recurrence. TRE is extremely accessible with no calorie counting or financial burden to the patient, individuals just shorten their eating window daily.

The aim of this trial is to examine the feasibility and acceptability of 24-weeks of 8-h TRE among female breast cancer patients initiating chemotherapy. Additionally the preliminary effect of 8-h TRE on treatment outcomes, treatment related side-effects, and patient reported quality of life and fatigue will be explored. Exploratory outcomes will include glucose regulation, body weight, body composition, IGF-1, IGFBP3, SHBG, estradiol (e2), TNF-alpha, and hsCRP

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois Chicago
        • Contact:
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Robert H. Lurie Comprehensive Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard Care control
Participants assigned to standard care will follow the recommendations by American Association for Cancer Research and the American Cancer Society.
Experimental: 8-h TRE
Participants assigned to this arm will follow the 8-h TRE protocol. Participants will consume food ad libitum (no calorie or food restrictions) during a self-selected 8-h eating window (beginning at 10:00 am, 11:00am, or 12:00 pm) and fasting for 16 hours daily. They will follow this same eating pattern for the length of the intervention. Calorie free drinks such as water, black coffee, and diet soda, are permitted during the fasting period. The eating window will allow for a typical breakfast/lunch/dinner eating pattern.
Behavioral: Time restricted eating
Participants assigned to this arm will follow the 8-h TRE protocol. Participants will consume food ad libitum (no calorie or food restrictions) during a self-selected 8-h eating window (beginning at 10:00 am, 11:00am, or 12:00 pm) and fasting for 16 hours daily. They will follow this same eating pattern for the length of the intervention. Calorie free drinks such as water, black coffee, and diet soda, are permitted during the fasting period. The eating window will allow for a typical breakfast/lunch/dinner eating pattern.
Other Names:
  • TRE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment feasibility
Time Frame: 24 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
24 weeks
TRE Acceptibility
Time Frame: 24 weeks
attendance at study visits, completeness of data, and overall and treatment specific loss to follow-up/withdrawal will be closely monitored
24 weeks
TRE adherence
Time Frame: 24 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.
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in body weight
Time Frame: 24 weeks
24 weeks
Change in HbA1c
Time Frame: 24 weeks
24 weeks
Fatigue
Time Frame: 24 weeks
The Functional assessment of Cancer therapy - fatigue
24 weeks
Treatment related side effects
Time Frame: 24 weeks
Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events, PRO-CTCAE
24 weeks
Change in Insulin
Time Frame: 24 weeks
24 weeks
Change in glucose
Time Frame: 24 weeks
24 weeks
Change in TNF-alpha
Time Frame: 24 weeks
24 weeks
Change in fat mass
Time Frame: 24 weeks
24 weeks
Change in lean mass
Time Frame: 24 weeks
24 weeks
Change in visceral adiposity
Time Frame: 24 weeks
24 weeks
Quality of Life
Time Frame: 24 weeks
European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire
24 weeks
Biochmical blood count Safety
Time Frame: 24 weeks
CBC
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 27, 2026

First Submitted That Met QC Criteria

January 27, 2026

First Posted (Actual)

February 4, 2026

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Study2021-0974

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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