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Recruiting NCT05259410

Time Restricted Eating During Chemotherapy for Breast Cancer

Trial Parameters

Condition Breast Cancer Female
Sponsor University of Illinois at Chicago
Study Type INTERVENTIONAL
Phase N/A
Enrollment 40
Sex FEMALE
Min Age 25 Years
Max Age 99 Years
Start Date 2022-08-01
Completion 2026-03-01
Interventions
TREMedTRE

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 negati

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