Reducing Respiratory Symptoms of Pulmonary Irradiation in Interstitial Lung Disease
NCT05986318 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 98
Last updated 2026-03-09
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.
Conditions
Interventions
- DIETARY_SUPPLEMENT
-
N-Acetyl cysteine
NAC capsules
- DRUG
-
Dexamethasone Oral
Dexamethasone tablets
- DIETARY_SUPPLEMENT
-
N-Acetyl cysteine Placebo
Matching placebo for NAC capsules
- DRUG
-
Dexamethasone Placebo
Matching placebo for dexamethasone tablets
- RADIATION
-
Radiation Therapy
All participants will receive radical pulmonary radiation therapy. Conventional techniques or stereotactic ablative radiotherapy will be used.
Sponsors & Collaborators
-
London Health Sciences Centre
collaborator OTHER -
Centre Hospitalier de l'Universite de Montreal (CHUM)
collaborator UNKNOWN -
David Palma
lead OTHER
Principal Investigators
-
David Palma, MD · London Health Sciences Centre, Lawson Health Research Institute
-
Houda Bahig, MD · Centre Hospitalier de l'Universite de Montreal
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-01-07
- Primary Completion
- 2028-07-01
- Completion
- 2032-12-31
Countries
- Canada
Study Locations
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