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OpenTrials
Active, Not Recruiting

NCT Number: NCT05919147

The Neuroendocrine Effects of Pioglitazone in Patients With Cancer and Cachexia

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pioglitazone 45 mg

Drug

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

Placebo

Drug

Placebo will have the same appearance as the active drug.

Primary outcomes

  1. Change in skeletal muscle insulin sensitivity

    Time frame: Baseline, Week 12

    Quantified using hyperinsulinemic-euglycemic clamp

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Official study title

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

Acronym: TRACE-1

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jun 26, 2023
Registry last updated
Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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