Reducing Respiratory Symptoms of Pulmonary Irradiation in Interstitial Lung Disease

NCT05986318 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2026-03-09

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05986318 on ClinicalTrials.gov