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

NCT03700437 | Completed DMC

• 1 other identifier: IUSCC-0662
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Non-small Cell Lung Cancer

Keywords

fasting; diet; chemo-immunotherapy; lung cancer; circulating tumor cells

Outcome Measures

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

  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)

Study Arms (1)

Fasting-Mimicking Diet (FMD)

EXPERIMENTAL

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

Fasting-Mimicking Diet OTHER

Chemo-immunotherapy + FMD (fast-mimicking diet)

Fasting-Mimicking Diet (FMD)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years at the time of informed consent
• Ability to provide written informed consent and HIPAA authorization
• Eastern cooperative group (ECOG) performance status of 0 to 2
• Histologically confirmed Non-Small Cell Lung Cancer (NSCLC) and have advanced disease.
• BMI ≥ 19
• 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
• If a patient is on a treatment that lowers their ANC, their ANC has to be ≥ 1500 on the first day of fasting

You may not qualify if:

• Self-reported weight loss of \> 10% in the 6 weeks prior to study entry
• History of diabetes mellitus or patients with a known recent elevated A1c \> 6
• History of symptomatic hypoglycemia
• Prior therapies with inhibitors of IGF-1 such as
• Linsitinib
• Picropodophyllin
• Concurrent use of somatostatin
• Concurrent use of immunosuppressive medications including sirolimus, tacrolimus, mycophenolate mofetil, azathioprine, prednisone, dexamethasone, or cyclosporine
• Significant food allergies (screening checklist in Appendix 3) which would make the subject unable to consume the food provided
• 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.
• Pregnant or lactating females are not eligible.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (3)

Eskenazi Hospital

Indianapolis, Indiana, 46202, United States

Location

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

Location

Indiana University Melvin & Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Fasting; Lung Neoplasms; Neoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Feeding Behavior; Behavior; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shadia Jalal, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Medicine

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: October 9, 2018
• Study Start: November 2, 2018
• Primary Completion: March 23, 2022
• Study Completion: March 23, 2022
• Last Updated: May 12, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)