NCT07387445 · University of Illinois at Chicago
Feasibility and Acceptibility of a Multi-site Trial of Time Restircted Eating During Chemotheraply for Breast Cancer.
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
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 measures
Recruitment feasibility
Time frame: 24 weeks
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
TRE Acceptibility
Time frame: 24 weeks
attendance at study visits, completeness of data, and overall and treatment specific loss to follow-up/withdrawal will be closely monitored
TRE adherence
Time frame: 24 weeks
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Chronic pancreatitis
- History of solid organ transplantation
Where
- Chicago, Illinois
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 1, 2026 · Source of record for eligibility and locations