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

Sponsor

Indiana University (Other)

Overall Status

Completed

CT.gov ID

NCT03700437

Collaborator

(none)

Enrollment

Locations

Arm

40.6

Actual Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer	Other: Fasting-Mimicking Diet	N/A

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

To assess a patient's willingness to fast for second cycle

Correlative Objectives

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)
To assess spheroid formation from circulating tumor cells (CTCs) isolated from patients post FMD as compared to baseline (prior to fasting)
To measure the changes in immune markers prior to and after administering the FMD

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Nov 2, 2018

Actual Primary Completion Date :

Mar 23, 2022

Actual Study Completion Date :

Mar 23, 2022

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

Proportion of the patients who can finish the FMD without serious adverse events [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)]
To assess feasibility, compliance will be measured by a daily log

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

≥ 18 years at the time of informed consent
Ability to provide written informed consent and HIPAA authorization
Eastern cooperative group (ECOG) performance status of 0 to 2
Histologically confirmed Non-Small Cell Lung Cancer (NSCLC) and have advanced disease.
BMI ≥ 19
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
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:

Self-reported weight loss of > 10% in the 6 weeks prior to study entry
History of diabetes mellitus or patients with a known recent elevated A1c > 6
History of symptomatic hypoglycemia
Prior therapies with inhibitors of IGF-1 such as
Linsitinib
Picropodophyllin
Concurrent use of somatostatin
Concurrent use of immunosuppressive medications including sirolimus, tacrolimus, mycophenolate mofetil, azathioprine, prednisone, dexamethasone, or cyclosporine
Significant food allergies (screening checklist in Appendix 3) which would make the subject unable to consume the food provided
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.
Pregnant or lactating females are not eligible.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eskenazi Hospital	Indianapolis	Indiana	United States	46202
2	Indiana University Hospital	Indianapolis	Indiana	United States	46202
3	Indiana University Melvin & Bren Simon Cancer Center	Indianapolis	Indiana	United States	46202