TRACE-1: The Neuroendocrine Effects of Pioglitazone in Patients With Lung Cancer and Cachexia

Sponsor

Pennington Biomedical Research Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05919147

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this clinical trial is evaluate the effect of pioglitazone compared with placebo on skeletal muscle insulin sensitivity in subjects with advanced non-small-cell lung cancer and cachexia.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Drug: Pioglitazone 45 mg Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Neuroendocrine Effects of Pioglitazone in Patients With Advanced Non-Small-Cell Lung Cancer and Cachexia

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jun 30, 2025

Anticipated Study Completion Date :

Jun 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pioglitazone	Drug: Pioglitazone 45 mg The dose of pioglitazone will not exceed 45 mg once daily. Pioglitazone dose will titrate progressively over the first three weeks.
Placebo Comparator: Placebo	Drug: Placebo Placebo will have the same appearance as the active drug.

Arm

Intervention/Treatment

Experimental: Pioglitazone

Drug: Pioglitazone 45 mg

The dose of pioglitazone will not exceed 45 mg once daily. Pioglitazone dose will titrate progressively over the first three weeks.

Placebo Comparator: Placebo

Drug: Placebo

Placebo will have the same appearance as the active drug.

Outcome Measures

Primary Outcome Measures

Change in skeletal muscle insulin sensitivity [Baseline, Week 12]
Quantified using hyperinsulinemic-euglycemic clamp

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ≥18 years
Documented histologic or cytologic diagnosis of non-small-cell lung cancer that is locally advanced and inoperable or metastatic (e.g., spread to distant organs)
Cachexia defined by Fearon criteria
Insulin resistance syndrome, defined with the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Ability to provide written informed consent, willing and able to comply with all scheduled visits, treatment plans, laboratory tests, and other study procedures
Provide written approval by a qualified healthcare professional
Allow the collection and storage of biospecimens and data for future use

Exclusion Criteria:

Prior diagnosis of type 2 diabetes
Prior or current thiazolidinedione (TZD) therapy
Known hypersensitivity to TZD
New York Heart Association (NYHA) class I-IV heart failure
History of or actively treated bladder cancer
Current use of CYP2C inhibitor (e.g., gemfibrozil) or CYP2C inducer (e.g., rifampin)
Inadequate hepatic function
Currently pregnant, breastfeeding, or planning to become pregnant within the next 16 weeks
Contraindications to magnetic resonance imaging (e.g., implanted cardiac device, cochlear implant)
Any other condition that, in the investigator's opinion, would preclude participation or successful compliance with the protocol

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pennington Biomedical Research Center	Baton Rouge	Louisiana	United States	70808

Sponsors and Collaborators

Pennington Biomedical Research Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Justin Brown, Director, Cancer Metabolism Program, Pennington Biomedical Research Center

ClinicalTrials.gov Identifier:

NCT05919147

Other Study ID Numbers:

PBRC 2023-013

First Posted:

Jun 26, 2023

Last Update Posted:

Jun 26, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Lung Neoplasms

Cachexia

Pioglitazone

Study Results

No Results Posted as of Jun 26, 2023