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RECRUITING
NCT05986318
PHASE2

Reducing Respiratory Symptoms of Pulmonary Irradiation in Interstitial Lung Disease

Sponsor: David Palma

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

98

Start Date

2025-01-07

Completion Date

2032-12-31

Last Updated

2026-03-09

Healthy Volunteers

No

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.

Locations (3)

BC-Cancer Agency - Vancouver

Vancouver, British Columbia, Canada

Verspeeten Family Cancer Centre, London Health Sciences Centre

London, Ontario, Canada

Centre Hospitalier de l'Universite de Montreal (CHUM)

Montreal, Quebec, Canada