Reducing Respiratory Symptoms of Pulmonary Irradiation in Interstitial Lung Disease

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.

Trial Details

NCT ID
NCT05986318
Phase
PHASE2
Sponsor
David Palma
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • N-Acetyl cysteine
  • Dexamethasone Oral
  • N-Acetyl cysteine Placebo
  • Dexamethasone Placebo
  • Radiation Therapy
Locations (sample)
  • Vancouver, British Columbia, Canada|49.24966,-123.11934
  • London, Ontario, Canada|42.98339,-81.23304
  • Montreal, Quebec, Canada|45.50884,-73.58781

Key Eligibility Criteria

  • Lung cancer or 1-2 oligometastatic pulmonary lesions planned for radical intent radiotherapy \[minimal Biologically Effective Does (BED) of 48 Gy10…
  • Pathologically (histologically or cytologically) proven diagnosis of cancer is not required, but strongly recommended.
  • If the risk of biopsy is unacceptable, pathologic confirmation is not required providing there is growth over time on Computed Tomography (CT) imag…
  • Fibrotic Interstitial Lung Disease (ILD) of any subtype, as diagnosed by a respirologist and confirmed by central review

For full eligibility, visit ClinicalTrials.gov.

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