The Neuroendocrine Effects of Pioglitazone in Patients with Cancer and Cachexia (TRACE-1)

Pennington Biomedical Research Center

Status and phase

Active, not recruiting

Phase 2

Conditions

Lung Cancer

Treatments

Drug: Placebo

Drug: Pioglitazone 45 mg

Study type

Interventional

Funder types

Other

Identifiers

NCT05919147

PBRC 2023-013

Details and patient eligibility

About

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.

Enrollment

24 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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