The Neuroendocrine Effects of Pioglitazone in Patients With Cancer and Cachexia

Lung Cancer Clinical Trial

— TRACE-1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05919147
• Other study ID #: PBRC 2023-013
• Status: Recruiting
• Phase: Phase 2
• Start date: July 18, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: April 2024
• Source: Pennington Biomedical Research Center
• Contact: Justin Brown
• Phone: (225) 763-2715
• Email: justin.brown[@]pbrc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age =18 years

• Documented histologic or cytologic diagnosis of non-small-cell lung cancer or gastrointestinal 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

Related Conditions & MeSH terms

• Cachexia
• Lung Cancer

Intervention

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
Placebo will have the same appearance as the active drug.

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in skeletal muscle insulin sensitivity	Quantified using hyperinsulinemic-euglycemic clamp	Baseline, Week 12