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CompletedNCT03700437Updated May 12, 2022

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

An interventional study of Fasting-Mimicking Diet in Non-small Cell Lung Cancer, sponsored by Indiana University. Completed at 3 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-05-12.

Sponsored by Indiana University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The purpose of this study is to learn the effects of fasting on cancer cells while you get maintenance treatment.

Read the 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
02

Conditions studied

  • Non-small Cell Lung Cancer

Keywords

  • fasting
  • diet
  • chemo-immunotherapy
  • lung cancer
  • circulating tumor cells
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 12 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Indiana University is the lead sponsor of 958 studies on the registry; 200 are open to participants now.

Of its 142 completed or terminated interventional studies of FDA-regulated products, 112 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • 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

Interventions

  • OtherFasting-Mimicking Diet

    Chemo-immunotherapy + FMD (fast-mimicking diet)

06

What researchers measure

Primary outcomes

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

    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)

07

Study locations

3 sites
  • Eskenazi Hospital
    Indianapolis, Indiana 46202, United States
  • Indiana University Hospital
    Indianapolis, Indiana 46202, United States
  • Indiana University Melvin & Bren Simon Cancer Center
    Indianapolis, Indiana 46202, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03700437
Lead sponsor
Indiana University
Responsible party
Shadia Jalal (Associate Professor of Clinical Medicine, Indiana University) — Principal investigator
First posted
Oct 9, 2018
Start date
Nov 2, 2018
Primary completion
Mar 23, 2022
Completion
Mar 23, 2022
Last update
May 12, 2022

Study contacts

Shadia Jalal, MD
principal investigator · Indiana University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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