Actively Recruiting

Phase Not Applicable
Age: 25Years - 99Years
FEMALE
NCT05259410

Time Restricted Eating During Chemotherapy for Breast Cancer

Led by University of Illinois at Chicago · Updated on 2025-10-01

40

Participants Needed

1

Research Sites

186 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Time Restricted Eating During Chemotherapy for Breast Cancer

Who Can Participate

Age: 25Years - 99Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 25 to 99 years at time of consent
  • ECOG performance status 0 or 1
  • Histologically confirmed stage I to III breast cancer
  • Adequate organ function with absolute neutrophil count 215000/bcL
  • All screening labs obtained within 30 days prior to registration
  • Ability to provide written informed consent and HIPAA authorization
  • Women of childbearing potential must have a negative pregnancy test
  • Ability to understand and comply with study procedures for the entire study duration
Not Eligible

You will not qualify if you...

  • Metastatic disease or type 1 or 2 diabetes
  • BMI greater than or equal to 40 kg/m2 or less than 25 kg/m2
  • Pregnant or nursing women
  • Night shift workers
  • History of eating disorders
  • Significant weight gain or loss greater than 4 kg within 3 months prior to study
  • Active infection requiring systemic therapy
  • Uncontrolled HIV/AIDS or active viral hepatitis
  • Prior or concurrent malignancy interfering with study assessment
  • Any mental or medical condition preventing informed consent or participation
  • Other major comorbidities as determined by the study principal investigator
  • Illicit drug use or excessive alcohol use (more than 2 drinks per day)
  • Participation in Weight Watcher's or another weight loss program
  • History of myocardial infarction, stroke, congestive heart failure, chronic hepatitis, cirrhosis, chronic pancreatitis
  • History of solid organ transplantation

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Illinois Chicago

Chicago, Illinois, United States, 60612

Actively Recruiting

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Research Team

K

Kelsey Gabel, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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