CompletedNot applicableNCT03700437
Official study title

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

Study summary

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

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Key things to know

Main goalSupportive Care

This describes the study’s primary purpose.

What is being studiedFasting-Mimicking Diet

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated May 12, 2022 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?3 U.S. locations

Locations may change over time.

Who runs it?Indiana University

Study sponsor

01
Study overview

What this study is about

Purpose
Supportive Care
Study type
Interventional
Phase
Not applicable
Sponsor
Indiana University
Interventions being studied
Other: Fasting-Mimicking Diet
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Eskenazi HospitalIndianapolis, Indiana
  • Indiana University HospitalIndianapolis, Indiana
  • Indiana University Melvin & Bren Simon Cancer CenterIndianapolis, Indiana

Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 12, 2022. Always confirm current availability with the study team.

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