Time restricted eating during chemotherapy for breast cancer
The Safety and Efficacy of Time Restricted Eating Alone or Combined the Mediterranean Diet During Chemotherapy for Breast Cancer
This study is testing if a specific eating schedule combined with a healthy diet can help women with breast cancer feel better during chemotherapy and manage side effects.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 25 Years to 99 Years |
| Sex | Female |
| Sponsor | University of Illinois at Chicago Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT05259410 on ClinicalTrials.gov |
What this trial studies
This research investigates the effects of time restricted eating (TRE) combined with a Mediterranean diet on women undergoing chemotherapy for breast cancer. The study aims to determine if TRE can improve treatment-related outcomes, reduce side effects, and limit weight gain compared to standard care. By focusing on a daily eating window without calorie counting, the approach seeks to enhance adherence and patient quality of life while potentially improving clinical outcomes. The study will include women aged 25-99 with histologically confirmed Stage I-III breast cancer and adequate organ function.
Who should consider this trial
Good fit: Ideal candidates are women aged 25-99 with Stage I-III breast cancer who can comply with study procedures.
Not a fit: Patients with metastatic breast cancer or those with a BMI outside the specified range may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the effectiveness of chemotherapy and improve overall patient well-being during treatment.
How similar studies have performed: Preliminary studies on intermittent fasting and dietary interventions during chemotherapy have shown promising results, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 * Stroke * Congestive heart failure * Chronic hepatitis * Cirrhosis * Chronic pancreatitis * History of solid organ transplantation
Where this trial is running
Chicago, Illinois
- University of Illinois Chicago — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Kelsey Gabel, MS, RD, PhD — Uic
- Study coordinator: Kelsey Gabel, PhD
- Email: kdipma2@uic.edu
- Phone: 312-413-8911
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.