Reducing Respiratory Symptoms of Pulmonary Irradiation in Interstitial Lung Disease

Sponsor
David Palma
Study ID
NCT05986318
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • N-Acetyl cysteine — DIETARY_SUPPLEMENT
    NAC capsules
  • Dexamethasone Oral — DRUG
    Dexamethasone tablets
  • N-Acetyl cysteine Placebo — DIETARY_SUPPLEMENT
    Matching placebo for NAC capsules
  • Dexamethasone Placebo — DRUG
    Matching placebo for dexamethasone tablets
  • Radiation Therapy — RADIATION
    All participants will receive radical pulmonary radiation therapy. Conventional techniques or stereotactic ablative radiotherapy will be used.

Study Details

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.

Key Dates

First listed
Aug 14, 2023
Start date
Jan 7, 2025
Status verified
Mar 2026
Primary completion
Jul 1, 2028
Completion
Dec 31, 2032

Study Design

Enrollment
98 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: NAC + Corticosteroids
    Participants will take 600 mg of active NAC orally, three times daily, for 60 days. Participants will also take 4 mg of active dexamethasone, orally, once daily for 10 days, then 2 mg, orally, once daily for 5 days, then 1 mg, orally, once daily for 5 days. All participants will be treated with radical pulmonary radiation therapy.
  • Active Comparator: Corticosteroids + NAC Placebo
    Participants will take 4 mg of active dexamethasone, orally, once daily for 10 days, then 2 mg, orally, once daily for 5 days, then 1 mg, orally, once daily for 5 days. Participants will also take matching NAC placebo orally, three times daily, for 60 days. All participants will be treated with radical pulmonary radiation therapy.
  • Active Comparator: NAC + Dexamethasone Placebo
    Participants will take 600 mg of active NAC orally, three times daily, for 60 days. Participants will also take matching dexamethasone placebo (4 mg for 10 days, then 2 mg for 5 days, then 1 mg for 5 days), orally, once daily. All participants will be treated with radical pulmonary radiation therapy.
  • Placebo Comparator: NAC Placebo + Dexamethasone Placebo
    Participants will take matching NAC placebo orally, three times daily, for 60 days. Participants will also take matching dexamethasone placebo (4 mg for 10 days, then 2 mg for 5 days, then 1 mg for 5 days), orally, once daily. All participants will be treated with radical pulmonary radiation therapy.

Primary Outcome Measure

Rate of Grade 2-5 Dyspnea within 6 Months Post Radiation Measured by the Common Terminology Criteria for Adverse Events (CTCAE) Version 5 [ Time Frame: Up to 6 months post radiation therapy ]

Central Contacts

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