Time Restricted Eating During Chemotherapy for Breast Cancer
Recruiting · NCT05259410 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Illinois at Chicago
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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 it is running
1 location listed across 1 US state.
- University of Illinois Chicago - Chicago, Illinois, United States