Recruiting

Time Restricted Eating

Sponsor:

University of Illinois at Chicago

Code:

NCT07387445

Conditions

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

Breast Neoplasm Female

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 25 - 70+

Healthy Volunteers: Not accepted

Interventions

Time restricted eating

Study Details

Brief summary:

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.

Conditions

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

Breast Neoplasm Female

Breast Cancer

Study ID

NCT07387445

Start date

Feb 1, 2026

Status verified date

Apr, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 25 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Recruitment feasibility [ Time Frame: 24 weeks ]
  • TRE Acceptibility [ Time Frame: 24 weeks ]
  • TRE adherence [ Time Frame: 24 weeks ]

Central Contacts and Locations

Central contacts

Kelsey Gabel, RD, PhD

312-413-8911kdipma2@uic.edu

Locations

Robert H. Lurie Comprehensive Cancer Center

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Kelsey Gabel, RD PhD

(312) 413-8911fastlab@uic.edu

University of Illinois Chicago

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Kelsey Gabel, RD, PhD

312-413-8911kdipma2@uic.edu

More Information

Sponsor

University of Illinois at Chicago

Last update posted

May 1, 2026

Last verified

Apr, 2026

Keywords

  • breast cancer
  • fasting
  • intermittent fasting
  • time restricted eating
  • chemotherapy initiation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Illinois at Chicago on 2026-05-01.