Time Restricted Eating During Chemotherapy for Breast Cancer

NCT05259410 | Recruiting DMC

• 1 other identifier: 2021-0974
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Breast cancer is the most common cancer in the United States however, little is known about how diet can affect cancer treatment. Pre-clinical murine studies report intermittent fasting increases effectiveness of chemotherapy and decreases treatment related adverse events. The proposed research will demonstrate that time restricted eating, a form of intermittent fasting, will improve treatment related outcomes, patient related outcomes, and limit treatment related weight gain and fat mass accretion.Time restricted eating combined with a mediterranean diet will also be feasible and improve cardiometabolic risk more than TRE alone or standard care.

Conditions

Breast Cancer Female

Outcome Measures

Primary Outcomes (1)

• Feasibility 8-h TRE

  enrollment rate

  12 weeks

Secondary Outcomes (7)

• Relative dose intensity

  12 weeks

• Treatment side effects

  12 weeks

• EROTC quality of life score

  12 weeks

• Body weight change

  12 weeks

• Body composition

  12 weeks

Study Arms (3)

Time restricted eating

EXPERIMENTAL

Participants will eat all food within the same self selected 8 hour window daily.

Behavioral: TRE

Standard care

NO INTERVENTION

Current standard care is to eat enough calories and protein to maintain weight and lean mass.

Med TRE

EXPERIMENTAL

Participants will eat a mediterranean style diet within the same self selected 8 hour window daily.

Behavioral: MedTRE

Interventions

TRE BEHAVIORAL

All food eaten within the same self-selected 8 hour eating window daily, water fasting the remaining hours of the day.

Time restricted eating

MedTRE BEHAVIORAL

A mediterranean style diet will be eaten within the same self-selected 8 hour eating window daily, water fasting the remaining hours of the day.

Med 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois Chicago

Chicago, Illinois, 60612, United States

RECRUITING

Study Officials

• Kelsey Gabel, MS, RD, PhD

  UIC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelsey Gabel, PhD

CONTACT

312-413-8911; kdipma2@uic.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor, Postdoctoral Research Associate

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: February 28, 2022
• Study Start: August 1, 2022
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)