Reducing respiratory symptoms in lung cancer patients with interstitial lung disease during radiation therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II randomized controlled trial aims to evaluate the effectiveness of N-acetylcysteine and corticosteroids in reducing respiratory symptoms in lung cancer patients who also have interstitial lung disease (ILD) and are undergoing radiation therapy. Patients will be randomly assigned to receive either the active treatments or placebos in a 2 x 2 factorial design. The primary outcome will be the reduction in dyspnea severity, assessed using the Common Terminology Criteria for Adverse Events. The study seeks to address the increased risk of radiation pneumonitis in this vulnerable patient population.

Why it matters

Who can join: the full rules

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, 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
* Eastern Cooperative Oncology Group (ECOG) performance status 0-3
* Age ≥ 18
* Life expectancy \> 6 months
* Patients are allowed to receive anti-fibrotic agents used in the treatment of Idiopathic Pulmonary Fibrosis (IPF) or non-IPF fibrotic ILD (e.g. nintedanib, pirfenidone) and/or corticosteroids, if those are part of their current ILD treatment regimen. Other immunosuppressive drugs such as mycophenolate, azathioprine, cyclophosphamide, and rituximab must be stopped for 2 weeks prior and 2 weeks after Radiation Therapy (RT).
* Concurrent standard chemotherapy is allowed where indicated. All other systemic therapies, including biologic targeted agents or immunotherapy, or any drugs with known radiosensitive effects, must be stopped for 2 weeks prior and 2 weeks after treatment.

Exclusion Criteria:

* 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
* Pregnancy

  * If not pregnant, use of effective contraception methods for women of childbearing age is required which can include:

    * hormonal methods (e.g. oral, injected, implanted),
    * placement of an intrauterine device,
    * barrier methods (i.e. condoms),
    * sterilization of the partner (e.g. previous vasectomy)
    * abstinence
  * Women who become pregnant should stop taking NAC and/or dexamethasone and inform their study doctor.
  * Male participants should use adequate forms of birth control with their partners.
* Currently breastfeeding
* Current or recent use of NAC
* Contraindications to dexamethasone or N-Acetyl Cysteine (NAC). These include:

  * Previous intolerance or allergy to dexamethasone or NAC
  * Scleroderma
  * Active infection
  * Glaucoma
  * Psychiatric disorder that could be exacerbated by dexamethasone
  * Cystinuria
  * Any other condition that the treating physician believes to be a contraindication to dexamethasone or NAC

Where it's running

• BC-Cancer Agency - Vancouver
  Vancouver, British Columbia, Canada Recruiting
• Saint John Regional Hospital-Horizon Health Network
  Saint John, New Brunswick, Canada Recruiting
• Verspeeten Family Cancer Centre, London Health Sciences Centre
  London, Ontario, Canada Recruiting
• Centre Hospitalier de l'Universite de Montreal (CHUM)
  Montreal, Quebec, Canada Recruiting

Study contacts

• Study coordinator: David Palma, MD
• Email: david.palma@lhsc.on.ca
• Phone: 519-685-8650

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.