RecruitingPhase 2NCT05986318

Reducing Respiratory Symptoms of Pulmonary Irradiation in Interstitial Lung Disease

Reducing Respiratory Symptoms of Pulmonary Irradiation in Interstitial Lung Disease: A 2x2 Factorial Randomized Phase II Trial Testing N-Acetyl Cysteine and Dexamethasone


Sponsor

David Palma

Enrollment

98 participants

Start Date

Jan 7, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether certain medications can reduce breathing symptoms and side effects in people with interstitial lung disease (ILD) — a chronic scarring lung condition — who need radiation therapy for lung cancer or tumors that have spread to the lung. **You may be eligible if...** - You have lung cancer or 1-2 tumors in the lung being treated with high-dose, curative-intent radiation therapy - You have a pre-existing interstitial lung disease (ILD) **You may NOT be eligible if...** - You are not receiving radiation therapy to the lung - You do not have interstitial lung disease - You have certain health conditions that make it unsafe to participate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTN-Acetyl cysteine

NAC capsules

DRUGDexamethasone Oral

Dexamethasone tablets

DIETARY_SUPPLEMENTN-Acetyl cysteine Placebo

Matching placebo for NAC capsules

DRUGDexamethasone Placebo

Matching placebo for dexamethasone tablets

RADIATIONRadiation 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

View Full Details on ClinicalTrials.gov

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NCT05986318


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