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Thiazolidinedione

Pioglitazone for Lung Cancer with Cachexia (TRACE-1 Trial)

Phase 2

Recruiting

Research Sponsored by Pennington Biomedical Research Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Documented histologic or cytologic diagnosis of non-small-cell lung cancer that is locally advanced and inoperable or metastatic (e.g., spread to distant organs)

Age ≥18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 12

Awards & highlights

TRACE-1 Trial Summary

This trial compares a diabetes medication to placebo to see if it helps advanced lung cancer patients with muscle wasting.

Who is the study for?

This trial is for adults over 18 with advanced non-small-cell lung cancer and cachexia, a condition causing weight loss and muscle wasting. Participants must have insulin resistance but not diabetes, be able to follow the study plan, and consent to biospecimen collection. Exclusions include heart failure, pregnancy, MRI contraindications, prior TZD therapy or sensitivity, bladder cancer history, certain drug use, and inadequate liver function.Check my eligibility

What is being tested?

The study tests if Pioglitazone (a medication) improves muscle insulin sensitivity in patients with lung cancer-related cachexia versus a placebo (inactive substance). Patients are randomly assigned to receive either Pioglitazone or placebo to compare effects on their body's response to insulin.See study design

What are the potential side effects?

Pioglitazone may cause fluid retention leading to swelling and weight gain; it can also increase risk of heart failure in some cases. Other side effects might include bone fractures in women and potential increases in bladder cancer risk.

TRACE-1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lung cancer is advanced and cannot be removed by surgery.

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I am 18 years old or older.

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I am experiencing significant weight loss due to my illness.

TRACE-1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in skeletal muscle insulin sensitivity

Side effects data

From 2013 Phase 3 trial • 936 Patients • NCT01183013

10%

Oedema peripheral

Hypertension

Back pain

Nasopharyngitis

Hyperglycaemia

Urinary tract infection

Headache

Pain in extremity

Bronchitis

Oedema

Diarrhoea

Arthralgia

Upper respiratory tract infection

Pneumothorax

Pancreatitis acute

Rectosigmoid cancer

Hairy cell leukaemia

Jaundice

Myocardial infarction

Intestinal haemorrhage

Pneumonia

Small intestine carcinoma

Bipolar disorder

Intervertebral disc protrusion

100%

80%

60%

40%

20%

Study treatment Arm

Pio15/Pio30

Pio30/Pio30

Pio45/Pio45

Lina5/Lina5

Lina5Pio15/Lina5Pio30

Lina5Pio30/Lina5Pio30

Lina5Pio45/Lina5Pio45

TRACE-1 Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: PioglitazoneExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pioglitazone 45 mg

2000

Completed Phase 4

~960

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Pennington Biomedical Research CenterLead Sponsor

305 Previous Clinical Trials

182,012 Total Patients Enrolled

Media Library

Pioglitazone (Thiazolidinedione) Clinical Trial Eligibility Overview. Trial Name: NCT05919147 — Phase 2

Lung Cancer Research Study Groups: Pioglitazone, Placebo

Lung Cancer Clinical Trial 2023: Pioglitazone Highlights & Side Effects. Trial Name: NCT05919147 — Phase 2

Pioglitazone (Thiazolidinedione) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05919147 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people able to participate in this experiment at the present time?

"Confirmation of this can be found on clinicaltrials.gov; the study, originally posted on July 1st 2023 and most recently updated June 22nd 2023 is not presently recruiting participants. However, there are 1659 other trials across various disciplines that currently welcome patients to partake in research."

Answered by AI

Has Pioglitazone been given the green-light by the FDA?

"After careful consideration, the safety of pioglitazone was rated 2 out of 3. This is due to a lack of evidence supporting efficacy, although there are some data points that suggest it could be safe for use in clinical trials."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Neuroendocrine Effects of Pioglitazone in Patients With Cancer and Cachexia

Justin Brown 2023. "The Neuroendocrine Effects of Pioglitazone in Patients With Cancer and Cachexia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05919147.