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

NCT07387445 | Recruiting DMC

• 1 other identifier: Study2021-0974
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Recruitment feasibility

  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

  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

  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 Outcomes (12)

• Quality of Life

  24 weeks

• Fatigue

  24 weeks

• Treatment related side effects

  24 weeks

• Biochmical blood count Safety

  24 weeks

• Change in Insulin

  24 weeks

Study Arms (2)

Standard Care control

NO INTERVENTION

Participants assigned to standard care will follow the recommendations by American Association for Cancer Research and the American Cancer Society.

8-h TRE

EXPERIMENTAL

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

Interventions

Time restricted eating BEHAVIORAL

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.

Also known as: TRE

8-h TRE

Eligibility Criteria

• Age: 25 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (2)

Robert H. Lurie Comprehensive Cancer Center

Chicago, Illinois, 60611, United States

RECRUITING

University of Illinois Chicago

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Fasting; Intermittent Fasting

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Feeding Behavior; Behavior

Central Study Contacts

Kelsey Gabel, RD, PhD

CONTACT

312-413-8911; kdipma2@uic.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: data collectors and sample analysis will be blinded to arm allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: A 24-week open-label controlled trial will be conducted. Forty women with stage I-IV breast cancer initiating chemotherapy will be recruited. Women will be assigned to 8-h TRE (self-selected start at 10am, 11am, or 12pm) ad-libitum eating during a 24-week self-selected 8 hour eating window and fasting 16- hours daily, or standard care for 24 weeks.

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 4, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

US (2)