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

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ClinicalTrials.gov Identifier: NCT03700437
Recruitment Status : Recruiting
First Posted : October 9, 2018
Last Update Posted : February 12, 2021
Sponsor:
Information provided by (Responsible Party):
Shadia Jalal, Indiana University

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 Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 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 : November 2, 2018
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


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)




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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03700437


Contacts
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Contact: Maggie Uhrich, RN 1 317-274-4505 muhrich@iu.edu

Locations
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United States, Indiana
Eskenazi Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Maggie Uhrich, RN    317-274-4505    muhrich@iu.edu   
Principal Investigator: Shadia Jalal, MD         
Indiana University Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Maggie Uhrich    317-274-4505    muhrich@iu.edu   
Principal Investigator: Shadia Jalal, MD         
Indiana University Melvin & Bren Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Maggie Uhrich, RN    317-274-4505    muhrich@iu.edu   
Principal Investigator: Shadia Jalal, MD         
Sponsors and Collaborators
Indiana University
Investigators
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Principal Investigator: Shadia Jalal, MD Indiana University
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Responsible Party: Shadia Jalal, Associate Professor of Clinical Medicine, Indiana University
ClinicalTrials.gov Identifier: NCT03700437    
Other Study ID Numbers: IUSCC-0662
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: February 12, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shadia Jalal, Indiana University:
fasting
diet
chemo-immunotherapy
lung cancer
circulating tumor cells
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms