Reducing Respiratory Symptoms of Pulmonary Irradiation in Interstitial Lung Disease — RESPIRE-ILD  

Lung Cancer Clinical Trial

Official title: Reducing Respiratory Symptoms of Pulmonary Irradiation in Interstitial Lung Disease: A 2x2 Factorial Randomized Phase II Trial Testing N-Acetyl Cysteine and Dexamethasone

Status Not yet recruiting

Clinical Trial Summary

In this double-blind phase II randomized controlled trial, patients with lung cancer or ≤2 oligometastatic pulmonary lesions and a concomitant diagnosis of ILD who are planned for radical Radiation Therapy (RT) will be randomized using a 2 x 2 factorial design to oral N-acetylcysteine (NAC) versus placebo, and also to short course corticosteroids versus placebo.

Clinical Trial Description

Radiation pneumonitis (RP) is the most common and main dose-limiting toxicity after thoracic RT. RP is characterized histologically by diffuse alveolar damage and acute vascular permeability induced by direct cytotoxic effect and oxidative stress, leading to the production of proinflammatory, profibrogenic and proangiogenic cytokines.

Patients with Interstitial Lung Disease (ILD) are at increased risk of developing lung cancer compared to the general population. Management of patients with lung cancer in the setting of a concomitant ILD is complex, as these patients are usually not good candidates for surgery or immunotherapy. In addition, patients with ILD, particularly fibrotic ILD, are also reportedly at increased risk of treatment-related toxicity from RT.

In the present study, investigators will test the following hypotheses:

1. The use of NAC with RT in patients with underlying ILD will lead to a clinically meaningful reduction in grade 2-5 dyspnea (as per Common Terminology Criteria for Adverse Events [CTCAE] version 5.0).

2. The use of corticosteroids with RT in patients with underlying ILD will lead to a clinically meaningful reduction in grade 2-5 dyspnea (as per CTCAE version 5.0). ;

Related Conditions & MeSH terms

• Interstitial Lung Disease
• Lung Cancer
• Lung Diseases
• Lung Diseases, Interstitial
• Signs and Symptoms, Respiratory

• NCT number: NCT05986318
• Study type: Interventional
• Source: Lawson Health Research Institute
• Contact: David Palma, MD
• Phone: 519-685-8650
• Email: david.palma@lhsc.on.ca
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 1, 2024
• Completion date: December 31, 2032