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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE September 25, 2018
First Posted Date  ICMJE October 9, 2018
Last Update Posted Date February 12, 2021
Actual Study Start Date  ICMJE November 2, 2018
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2021)
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
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
Current Secondary Outcome Measures  ICMJE Not Provided
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 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

  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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group 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)
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
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: February 9, 2021)
10
Original Estimated Enrollment  ICMJE
 (submitted: October 5, 2018)
40
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
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 February 2021

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