Actively Recruiting
Reducing Respiratory Symptoms of Pulmonary Irradiation in Interstitial Lung Disease
Led by David Palma · Updated on 2026-03-09
98
Participants Needed
3
Research Sites
416 weeks
Total Duration
On this page
Sponsors
D
David Palma
Lead Sponsor
L
London Health Sciences Centre
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Reducing Respiratory Symptoms of Pulmonary Irradiation in Interstitial Lung Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Lung cancer or 1-2 oligometastatic pulmonary lesions planned for radical intent radiotherapy with a minimal biologically effective dose of 48 Gy10 or equivalent
- Fibrotic Interstitial Lung Disease of any subtype diagnosed by a respirologist and confirmed by central review
- Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 3
- Life expectancy greater than 6 months
- Patients may be receiving anti-fibrotic agents or corticosteroids as part of their ILD treatment
- Concurrent standard chemotherapy is allowed where indicated
- Other immunosuppressive drugs must be stopped 2 weeks before and after radiation therapy
- Pathologic confirmation of cancer is strongly recommended but not required if biopsy risk is unacceptable, provided imaging shows growth or FDG avidity suggestive of malignancy
You will not qualify if you...
- Prior lung radiotherapy
- Current use of oral or intravenous corticosteroids
- Plans to receive other local therapy to the target lesion(s) during the study except at disease progression
- Any medical condition that could prevent radiotherapy or follow-up after radiotherapy
- Pregnancy or breastfeeding
- Women of childbearing age must use effective contraception methods
- Male participants must use adequate birth control with partners
- Current or recent use of N-acetylcysteine
- Contraindications to dexamethasone or N-acetylcysteine, including allergy, scleroderma, active infection, glaucoma, psychiatric disorders that could worsen with dexamethasone, cystinuria, or other physician-determined contraindications
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Trial Site Locations
Total: 3 locations
1
BC-Cancer Agency - Vancouver
Vancouver, British Columbia, Canada, V5Z 4E6
Actively Recruiting
2
Verspeeten Family Cancer Centre, London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
Actively Recruiting
3
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, Canada, H2X 0A9
Actively Recruiting
Research Team
D
David Palma, MD
CONTACT
H
Houda Bahig, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
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