NCT05259410 Time Restricted Eating During Chemotherapy for Breast Cancer
| NCT ID | NCT05259410 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Illinois at Chicago |
| Condition | Breast Cancer Female |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2022-08-01 |
| Primary Completion | 2026-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2022-08-01 with a primary completion date of 2026-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Kelsey Gabel, MS, RD, PhD
PRINCIPAL INVESTIGATOR
UIC
Frequently Asked Questions
Who can join the NCT05259410 clinical trial?
This trial is open to female participants only, aged 25 Years or older, up to 99 Years, studying Breast Cancer Female. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05259410 currently recruiting?
Yes, NCT05259410 is actively recruiting participants. Contact the research team at kdipma2@uic.edu for enrollment information.
Where is the NCT05259410 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT05259410 clinical trial?
NCT05259410 is sponsored by University of Illinois at Chicago. The principal investigator is Kelsey Gabel, MS, RD, PhD at UIC. The trial plans to enroll 40 participants.
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