The Neuroendocrine Effects of Pioglitazone in Patients With Cancer and Cachexia

A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Investigate 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.

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