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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05919147
Recruitment Status : Recruiting
First Posted : June 26, 2023
Last Update Posted : April 9, 2024
Sponsor:
Information provided by (Responsible Party):
Justin Brown, Pennington Biomedical Research Center

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: Pioglitazone 45 mg Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Neuroendocrine Effects of Pioglitazone in Patients With Cancer and Cachexia
Actual Study Start Date : July 18, 2023
Estimated Primary Completion Date : June 30, 2025
Estimated Study Completion Date : June 30, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Pioglitazone 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 Comparator: Placebo Drug: Placebo
Placebo will have the same appearance as the active drug.


Outcome Measures
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Primary Outcome Measures :
  1. Change in skeletal muscle insulin sensitivity [ Time Frame: Baseline, Week 12 ]
    Quantified using hyperinsulinemic-euglycemic clamp


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05919147


Contacts
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Contact: Justin Brown (225) 763-2715 justin.brown@pbrc.edu

Locations
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United States, Louisiana
Pennington Biomedical Research Center Recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: Justin Brown    225-763-2715    justin.brown@pbrc.edu   
Sponsors and Collaborators
Pennington Biomedical Research Center
More Information
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Responsible Party: Justin Brown, Director, Cancer Metabolism Program, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT05919147    
Other Study ID Numbers: PBRC 2023-013
First Posted: June 26, 2023    Key Record Dates
Last Update Posted: April 9, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Cachexia
Weight Loss
Body Weight Changes
Body Weight
 Thinness
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs