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

Primary Purpose

Non-small Cell Lung Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Fasting-Mimicking Diet

About this trial

This is an interventional supportive care trial for Non-small Cell Lung Cancer focused on measuring fasting, diet, chemo-immunotherapy, lung cancer, circulating tumor cells

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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
1. Linsitinib
2. 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.

Sites / Locations

Eskenazi Hospital
Indiana University Hospital
Indiana University Melvin & Bren Simon Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fasting-Mimicking Diet (FMD)

Arm Description

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.

Outcomes

Primary Outcome Measures

Proportion of the patients who can finish the FMD without serious adverse events

To assess feasibility, compliance will be measured by a daily log

Secondary Outcome Measures

Full Information

NCT ID

NCT03700437

First Posted

September 25, 2018

Last Updated

May 10, 2022

Sponsor

Indiana University

1. Study Identification

Unique Protocol Identification Number

NCT03700437

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 Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

November 2, 2018 (Actual)

Primary Completion Date

March 23, 2022 (Actual)

Study Completion Date

March 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Indiana University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-small Cell Lung Cancer

Keywords

fasting, diet, chemo-immunotherapy, lung cancer, circulating tumor cells

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fasting-Mimicking Diet (FMD)

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Fasting-Mimicking Diet

Intervention Description

Chemo-immunotherapy + FMD (fast-mimicking diet)

Primary Outcome Measure Information:

Title

Proportion of the patients who can finish the FMD without serious adverse events

Description

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shadia Jalal, MD

Organizational Affiliation

Indiana University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Eskenazi Hospital

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

Indiana University Hospital

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

Indiana University Melvin & Bren Simon Cancer Center

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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

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