Actively Recruiting
Time Restricted Eating During Chemotherapy for Breast Cancer
Led by University of Illinois at Chicago · Updated on 2026-05-01
40
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of time restricted eating (TRE), which involves eating all food within an 8-hour window daily, on women undergoing chemotherapy for breast cancer stages I-IV. The study aims to find out if TRE is feasible and acceptable for these patients and to explore its preliminary effects on treatment outcomes, side effects, quality of life, and fatigue. This research also examines biological markers like glucose regulation, body weight, and inflammatory factors to understand TRE's potential impact. Participants will be assigned to either standard care, which follows current nutritional recommendations, or to the 8-hour TRE group. Those in the TRE group will choose an 8-hour eating window starting at 10:00 am, 11:00 am, or 12:00 pm each day and fast for the remaining 16 hours, consuming food without calorie restrictions during the eating window. Calorie-free drinks such as water, black coffee, and diet soda are allowed during fasting. The intervention lasts 24 weeks, comparing three different eating window options to the control group. During the study, participants will be monitored for recruitment feasibility, TRE acceptability, and adherence over 24 weeks. Researchers will assess quality of life, fatigue, treatment side effects, safety through blood counts, and changes in insulin, glucose, body composition, and inflammatory markers. Participants must complete screening evaluations and provide informed consent. The study involves regular assessments throughout the 24-week intervention period.
CONDITIONS
Brief Title
Feasibility and Acceptibility of a Multi-site Trial of Time Restircted Eating During Chemotheraply for Breast Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 25 to 99 years at time of consent
- Able to speak English or Spanish (based on available interpreters)
- ECOG performance status of 0 or 1
- Histologically confirmed breast cancer stage I-III or stage IV with medical oncology approval
- Adequate organ function with absolute neutrophil count ≥ 1,500/µL
- All screening labs done within 30 days before registration
- Able to provide written informed consent and HIPAA authorization
- Women of childbearing potential must not be pregnant or breastfeeding and require a negative pregnancy test
- Ability to understand and comply with study procedures for entire study duration as determined by physician or designee
You will not qualify if you...
- Women with type 1 diabetes or insulin-dependent type 2 diabetes
- Women with BMI greater than 45 kg/m2 or less than 18.5 kg/m2
- Pregnant or nursing women
- Shift workers
- Women with a history of eating disorders
- Significant weight gain or loss (>4 kg) within 3 months before study
- Uncontrolled HIV/AIDS or active viral hepatitis
- Prior malignancy within 5 years, recent chemotherapy within 1 year, or concurrent malignancy interfering with study
- Breast cancer recurrence as determined by treating oncologist
- Any mental or medical condition preventing informed consent or participation
- Major comorbidities as determined by the study investigator
- Illicit drug use within 3 months or excessive alcohol use (>2 drinks/day)
- Current participation in weight loss programs or use of weight loss medications
- History of myocardial infarction, congestive heart failure, chronic hepatitis, cirrhosis, chronic pancreatitis, or solid organ transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants follow an 8-hour time restricted eating (TRE) schedule daily while undergoing chemotherapy for breast cancer. They consume food during a self-selected 8-hour eating window and fast for 16 hours each day, with calorie-free drinks allowed during fasting.
Weekly visits for up to 24 weeks
Duration - Duration not specified beyond treatment
Participants will be monitored for treatment outcomes, side effects, quality of life, fatigue, and changes in body composition and biochemical markers after completing the 24-week TRE intervention.
Additional assessments may occur depending on study schedule
Trial Site Locations
Total: 2 locations
1
Robert H. Lurie Comprehensive Cancer Center
Chicago, Illinois, United States, 60611
Actively Recruiting
2
University of Illinois Chicago
Chicago, Illinois, United States, 60612
Actively Recruiting
Research Team
K
Kelsey Gabel, RD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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