The purpose of this study is to learn the effects of fasting on cancer cells while you get maintenance treatment.
Cancer cells use an increased supply of glucose to make energy and do not have protection against fasting that normal cells do. Because of this, researchers would like to study how fasting may help chemotherapy target cancer cells instead of normal cells. Initial studies suggest that fasting may decrease the side effects of chemotherapy and increase the chances of your cancer responding to the chemotherapy. Patient populations will have non-small cell lung cancer in which chemo-immunotherapy with carboplatin/pemetrexed and pembrolizumab have been recommended to treat the cancer as part of standard care. Primary Objective 1. To determine the feasibility and compliance of administering a fasting-mimicking diet (FMD) in patients with advanced NSCLC receiving maintenance therapy Secondary Objectives 1\. To assess a patient's willingness to fast for second cycle Correlative Objectives 1. To assess DNA damage via measurement of γ-Η2ΑΧ foci in PBMCs at baseline and following one cycle of FMD (day 21 or day 28) 2. To assess spheroid formation from circulating tumor cells (CTCs) isolated from patients post FMD as compared to baseline (prior to fasting) 3. To measure the changes in immune markers prior to and after administering the FMD
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
12
Chemo-immunotherapy + FMD (fast-mimicking diet)
Eskenazi Hospital
Indianapolis, Indiana, United States
Indiana University Hospital
Indianapolis, Indiana, United States
Indiana University Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, United States
Proportion of the patients who can finish the FMD without serious adverse events
To assess feasibility, compliance will be measured by a daily log
Time frame: Between screening/baseline (28 to 4 days before Cycle 1 Day 1) and Cycle 1 Day 21 or 28 (Cylces last 21 or 28 days, based on treatment)
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