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Spots Global Cancer Trial Database for Fasting-mimicking Diet With Chemo-immunotherapy in Non-small Cell Lung Cancer (NSCLC)

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We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Fasting-mimicking Diet With Chemo-immunotherapy in Non-small Cell Lung Cancer (NSCLC)

Official Title: Randomized Controlled Pilot Study to Evaluate Fasting-mimicking Diet in Patients Receiving Chemo-immunotherapy for Treatment of Metastatic Non-small Cell Lung Cancer

Study ID: NCT03700437

Study Description

Brief Summary: The purpose of this study is to learn the effects of fasting on cancer cells while you get maintenance treatment.

Detailed Description: 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

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Eskenazi Hospital, Indianapolis, Indiana, United States

Indiana University Hospital, Indianapolis, Indiana, United States

Indiana University Melvin & Bren Simon Cancer Center, Indianapolis, Indiana, United States

Contact Details

Name: Shadia Jalal, MD

Affiliation: Indiana University

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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