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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 : April 2, 2019
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 during chemo-immunotherapy.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Other: Fasting-Mimicking Diet Other: Regular 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 effect of fasting-mimicking diet (FMD) on circulating tumor cells (CTCs) in patients with advanced NSCLC receiving chemo-immunotherapy

  1. To compare an absolute reduction and/or a percentage reduction in CTCs in patients receiving FMD compared to regular diet (RD)
  2. To assess DNA damage via measurement of γ-Η2ΑΧ foci in CTCs compared to PBMCs of patients receiving FMD or RD

Secondary Objectives

  1. To determine the clinical efficacy of FMD compared to RD by comparing the response rate (RR) and progression-free survival (PFS)
  2. To demonstrate the safety profile of FMD in conjunction with chemo-immunotherapy

Correlative Objectives

  1. To demonstrate an increase in platinum lesions measured by ICP mass spectrometry in tumor tissue (when available) and PBMCs of patients receiving FMD compared to RD
  2. To demonstrate increase in tumor-infiltrating lymphocytes in patients undergoing FMD compared to RD by obtaining optional tumor tissue samples (when available)
  3. To determine effect of FMD on immune regulation compared to RD
  4. To demonstrate change in FDG avidity in patients receiving FMD compared to RD when optional post-treatment PET scans are available
  5. To determine compliance to FMD
  6. To determine effect of FMD on QoL compared to RD

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel 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 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

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)

Placebo Comparator: Regular Diet Control Arm
Participants in the control arm will receive dietary advice per the standard practice of treating physician, nutritionist and dietitian and will consume regular diet during first 4 cycles of chemo-immunotherapy
Other: Regular Diet
Chemo-immunotherapy + regular diet




Primary Outcome Measures :
  1. Change in circulating tumor cells (CTC) count in control arm [ Time Frame: Screening (28 to 4 days before Cycle 1 Day 1), Cycle 1 Day 1, Cycle 2 Day 1, End of Treatment (day 18 to day 36 of last cycle) (each cycle is 21 days long) ]
  2. Change in circulating tumor cells (CTC) count in Fasting Mimicking Diet (FMD) [ Time Frame: Screening (28 to 4 days before Cycle 1 Day 1), Baseline (21 to 4 days before Cycle 1 Day 1), Cycle 1 Day 1, Cycle 2 Day 1, End of Treatment (day 18 to day 36 of last cycle) (each cycle is 21 days long) ]
  3. γ-Η2ΑΧ foci in circulating tumor cells (CTCs) in control arm [ Time Frame: Cycle 1 Day 1, Cycle 2 Day 1, End of Treatment (day 18 to day 36 of last cycle) (each cycle is 21 days long) ]
    To assess DNA damage via measurement of γ-Η2ΑΧ foci in circulating tumor cells (CTCs) of patients receiving fasting-mimicking diet (FMD) or regular diet (RD)

  4. γ-Η2ΑΧ foci in circulating tumor cells (CTCs) in Fasting Mimicking Diet (FMD) [ Time Frame: Baseline (21 to 4 days before Cycle 1 Day 1), Cycle 1 Day 1, Cycle 2 Day 1, End of Treatment (day 18 to day 36 of last cycle) (each cycle is 21 days long) ]
    To assess DNA damage via measurement of γ-Η2ΑΧ foci in circulating tumor cells (CTCs) of patients receiving fasting-mimicking diet (FMD) or regular diet (RD)

  5. Peripheral blood mononuclear cells (PBMCs) in control arm [ Time Frame: Cycle 1 Day 1, Cycle 2 Day 1, End of Treatment (day 18 to day 36 of last cycle) (each cycle is 36 days long) ]
    To assess DNA damage via measurement of peripheral blood mononuclear cells (PBMCs) in patients receiving fasting-mimicking diet (FMD) or regular diet (RD)

  6. Peripheral blood mononuclear cells (PBMCs) in Fasting Mimicking Diet (FMD) [ Time Frame: Baseline (21 to 4 days before Cycle 1 Day 1), Cycle 1 Day 1, Cycle 2 Day 1, End of Treatment (day 18 to day 36 of last cycle) (each cycle is 21 days long) ]
    To assess DNA damage via measurement of peripheral blood mononuclear cells (PBMCs) in patients receiving fasting-mimicking diet (FMD) or regular diet (RD)


Secondary Outcome Measures :
  1. Objective tumor response rate (RR) [ Time Frame: Between Cycle 2 Day 8 through Cycle 3 Day 1 and Cycle 4 Day 18 through 36 ]
    measured by RECIST v1.1

  2. Progression-free survival (PFS) [ Time Frame: Between Cycle 2 Day 8 through Cycle 3 Day 1 and Cycle 4 Day 18 through 36 ]
    measured by RECIST v1.1

  3. Incidence of toxicity [ Time Frame: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, End of Treatment (day 18 to day 36 of last cycle) (each cycle is 21 days long) ]
    Toxicity assessed by Common Terminology Criteria for Adverse Events version 5.0



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 and ≤ 70 years old 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 or 1 at time of informed consent (see Appendix 2)
  4. Histologically confirmed Lung Adenocarcinoma for which combined chemo- immunotherapy in the form of carboplatin/pemetrexed and pembrolizumab is being utilized. Subjects must have untreated or newly diagnosed metastatic disease. . However, subjects may have received any local therapy for control/palliation for their Stage IV disease. They may also have received chemotherapy or immunotherapy prior to their enrollment for treatment at an earlier stage.
  5. Radiographically confirmed stage IV metastatic disease
  6. BMI ≥ 19
  7. Presence of at least 5 CTC at baseline

Exclusion Criteria:

  1. Self-reported weight loss of more than 10% in 6 weeks prior to informed consent due to malignancy
  2. History of diabetes mellitus or patients with a known recent elevated A1c > 6
  3. History of hypoglycemia
  4. Evidence of neutropenia (ANC <1500) at baseline
  5. Prior therapies with inhibitors of IGF-1

    1. Linsitinib
    2. Picropodophyllin
  6. Concurrent use of somatostatin
  7. Concurrent use of post-transplant immunosuppressive medications (sirolimus, tacrolimus, mycophenolate mofetil, azathioprine, prednisone, cyclosporine, etc.)
  8. Significant food allergies (screening checklist in Appendix 3) which would make the subject unable to consume the food provided
  9. Treatment with any investigational agent within 28 days prior to informed consent
  10. 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.

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     History of Changes
Other Study ID Numbers: IUSCC-0662
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019
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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Immunologic Factors
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
Physiological Effects of Drugs