N-Acetylcysteine for Lung Cancer with Interstitial Lung Disease

Reducing Respiratory Symptoms of Pulmonary Irradiation in Interstitial Lung Disease

Recruiting Phase 2 Interventional Study
Lung Cancer Interstitial Lung Disease
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
98 (estimated)
Sponsor
David Palma · Other
Who this trial is looking for

This trial is looking for patients with lung cancer or limited lung lesions who also have interstitial lung disease. Participants will receive either N-acetylcysteine or a placebo, along with a course of corticosteroids or another placebo, while undergoing radiation therapy.

Are You a Good Fit for This Trial?
Must be taking Anti-fibrotic agentsCorticosteroids
Rules you out Active infectionGlaucomaSclerodermaPsychiatric disorder

You may be able to join if

  • I have lung cancer or 1-2 lung lesions
  • I have been diagnosed with interstitial lung disease
  • I am 18 years old or older
  • I expect to live more than 6 months
  • I have an ECOG performance status of 0-3

You may not be able to join if

  • I have had lung radiotherapy before
  • I am currently using corticosteroids
  • I am planning to receive other local treatment while in this trial
  • I am pregnant
  • I am currently breastfeeding
  • I have had recent use of N-acetylcysteine
  • I have any medical condition that my doctor thinks prevents me from participating

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

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 Locations
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Eligibility Criteria
Inclusion Criteria: * Lung cancer or 1-2 oligometastatic pulmonary lesions planned for radical intent radiotherapy \[minimal Biologically Effective Does (BED) of 48 Gy10 (Gray) or biological equivalent\]. * Pathologically (histologically or cytologically) proven diagnosis of cancer is not required,…
Contacts

David Palma, MD

519-685-8650

david.palma@lhsc.on.ca

CONTACT

Houda Bahig, MD

514-890-8254

houda.bahig.chum@ssss.gouv.qc.ca

CONTACT