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

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

Study Overview

• Status: Completed
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Other: Fasting-Mimicking Diet

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

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Hospital
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Melvin & Bren Simon Cancer Center
    • Indianapolis, Indiana, United States, 46202
      • Eskenazi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. ≥ 18 years at the time of informed consent
2. Ability to provide written informed consent and HIPAA authorization
3. Eastern cooperative group (ECOG) performance status of 0 to 2
4. Histologically confirmed Non-Small Cell Lung Cancer (NSCLC) and have advanced disease.
5. BMI ≥ 19
6. Patients should be on maintenance therapy for advanced NSCLC as defined as treatment with single agent immunotherapy, single agent chemotherapy plus immunotherapy or single agent molecularly targeted therapy for a minimum of 2 months prior to study entry
7. If a patient is on a treatment that lowers their ANC, their ANC has to be ≥ 1500 on the first day of fasting

Exclusion Criteria:

1. Self-reported weight loss of > 10% in the 6 weeks prior to study entry
2. History of diabetes mellitus or patients with a known recent elevated A1c > 6
3. History of symptomatic hypoglycemia

4. Prior therapies with inhibitors of IGF-1 such as

   1. Linsitinib
   2. Picropodophyllin
5. Concurrent use of somatostatin
6. Concurrent use of immunosuppressive medications including sirolimus, tacrolimus, mycophenolate mofetil, azathioprine, prednisone, dexamethasone, or cyclosporine
7. Significant food allergies (screening checklist in Appendix 3) which would make the subject unable to consume the food provided
8. History or current evidence of any medical or psychiatric condition, therapy that may confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the participating subject as deemed by the treating investigator.
9. Pregnant or lactating females are not eligible.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Fasting-Mimicking Diet (FMD); Participants randomized to the intervention arm (FMD) will be provided with Chemolieve®, a plant-based FMD that provides ~300 calories/fasting day and includes all the food to be consumed during the dietary intervention including supplements Subjects will start the diet 3 days prior to chemo-immunotherapy and continue on the first day of chemo-immunotherapy for the first 4 cycles of therapy.

Other: Fasting-Mimicking Diet; Chemo-immunotherapy + FMD (fast-mimicking diet)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of the patients who can finish the FMD without serious adverse events	To assess feasibility, compliance will be measured by a daily log	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)

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: Shadia Jalal, MD, Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2018
• Primary Completion (Actual): March 23, 2022
• Study Completion (Actual): March 23, 2022

Study Registration Dates

• First Submitted: September 25, 2018
• First Submitted That Met QC Criteria: October 5, 2018
• First Posted (Actual): October 9, 2018

Study Record Updates

• Last Update Posted (Actual): May 12, 2022
• Last Update Submitted That Met QC Criteria: May 10, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: lung cancer; circulating tumor cells; diet; fasting; chemo-immunotherapy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: IUSCC-0662

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No