Health Trials

Reducing Respiratory Symptoms of Pulmonary Irradiation in Interstitial Lung Disease

ConditionsLung CancerInterstitial Lung Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDavid Palma

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.

Eligibility criteria

Qualifiers

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, 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) imaging and/or Fluorodeoxyglucose (FDG) avidity that is strongly suggestive of malignancy.

Fibrotic Interstitial Lung Disease (ILD) of any subtype, as diagnosed by a respirologist and confirmed by central review

Disqualifiers

Prior lung radiotherapy

Current use of oral or intravenous corticosteroids

Plans for the patient to receive other local therapy to the target lesion(s) while on this study, except at disease progression

Any medical condition that could, in the opinion of the investigator, preclude radiotherapy or prevent follow-up after radiotherapy

Trial design

Treatments tested in this trial

  • N-Acetyl cysteine
  • Dexamethasone Oral
  • N-Acetyl cysteine Placebo
  • Dexamethasone Placebo
  • Radiation Therapy

Treatment groups

98 Participants
are divided into 4 treatment groups

Sponsors and collaborators

David Palma

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Sponsor institution

London Health Sciences Centre

Collaborator

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborator

Source ClinicalTrials.gov