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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

Tracking Information
First Submitted Date  ICMJE September 25, 2018
First Posted Date  ICMJE October 9, 2018
Last Update Posted Date April 2, 2019
Actual Study Start Date  ICMJE November 2, 2018
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2019)
  • 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) ]
  • 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) ]
  • 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)
  • 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)
  • 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)
  • 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)
Original Primary Outcome Measures  ICMJE
 (submitted: October 5, 2018)
  • Change in circulating tumor cells (CTC) count [ Time Frame: baseline, cycle 2 day 8, cycle 4 day 8 ]
  • γ-Η2ΑΧ foci in circulating tumor cells (CTCs) [ Time Frame: baseline, cycle 2 day 8, cycle 4 day 8 ]
    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)
  • Peripheral blood mononuclear cells (PBMCs) [ Time Frame: baseline, cycle 2 day 8, cycle 4 day 8 ]
    To assess DNA damage via measurement of peripheral blood mononuclear cells (PBMCs) in patients receiving fasting-mimicking diet (FMD) or regular diet (RD)
Change History Complete list of historical versions of study NCT03700437 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2019)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2018)
  • Objective tumor response rate (RR) [ Time Frame: Cycle 2 Day 8 through Cycle 3 Day 1 and Cycle 4 Day 18 through 36 ]
    measured by RECIST v1.1
  • Progression-free survival (PFS) [ Time Frame: Cycle 2 Day 8 through Cycle 3 Day 1 and Cycle 4 Day 18 through 36 ]
    measured by RECIST v1.1
  • Incidence of toxicity [ Time Frame: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1 ]
    Toxicity assessed by Common Terminology Criteria for Adverse Events version 5.0
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fasting-mimicking Diet With Chemo-immunotherapy in Non-small Cell Lung Cancer (NSCLC)
Official Title  ICMJE Randomized Controlled Pilot Study to Evaluate Fasting-mimicking Diet in Patients Receiving Chemo-immunotherapy for Treatment of Metastatic Non-small Cell Lung Cancer
Brief Summary The purpose of this study is to learn the effects of fasting on cancer cells during chemo-immunotherapy.
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Non-small Cell Lung Cancer
Intervention  ICMJE
  • Other: Fasting-Mimicking Diet
    Chemo-immunotherapy + FMD (fast-mimicking diet)
  • Other: Regular Diet
    Chemo-immunotherapy + regular diet
Study Arms  ICMJE
  • 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.

    Intervention: Other: Fasting-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
    Intervention: Other: Regular Diet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 5, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Maggie Uhrich, RN 1 317-274-4505 muhrich@iu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03700437
Other Study ID Numbers  ICMJE IUSCC-0662
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Shadia Jalal, Indiana University
Study Sponsor  ICMJE Indiana University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shadia Jalal, MD Indiana University
PRS Account Indiana University
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP