NCT03700437

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
OTHER	Fasting-Mimicking Diet	Chemo-immunotherapy + FMD (fast-mimicking diet)

Timeline

• Start date: 2018-11-02
• Primary completion: 2022-03-23
• Completion: 2022-03-23
• First posted: 2018-10-09
• Last updated: 2022-05-12

Locations

3 sites across 1 country: United States