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Trial Title:
The Neuroendocrine Effects of Pioglitazone in Patients With Cancer and Cachexia
NCT ID:
NCT05919147
Condition:
Lung Cancer
Conditions: Official terms:
Cachexia
Pioglitazone
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Pioglitazone 45 mg
Description:
The dose of pioglitazone will not exceed 45 mg once daily. Pioglitazone dose will titrate
progressively over the first three weeks.
Arm group label:
Pioglitazone
Intervention type:
Drug
Intervention name:
Placebo
Description:
Placebo will have the same appearance as the active drug.
Arm group label:
Placebo
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Pennington Biomedical Research Center
Address:
City:
Baton Rouge
Zip:
70808
Country:
United States
Status:
Recruiting
Contact:
Last name:
Justin Brown
Phone:
225-763-2715
Email:
justin.brown@pbrc.edu
Start date:
January 3, 2024
Completion date:
June 30, 2026
Lead sponsor:
Agency:
Pennington Biomedical Research Center
Agency class:
Other
Source:
Pennington Biomedical Research Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05919147
