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N-Acetyl Cysteine + Corticosteroids for Lung Cancer (RESPIRE-ILD Trial)

Phase 2

Waitlist Available

Research Sponsored by David Palma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with lung cancer or 1-2 oligometastatic pulmonary lesions planned for radical intent radiotherapy with a minimal Biologically Effective Dose (BED) of 48 Gy10 (Gray) or biological equivalent

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

Must not have

Prior lung radiotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9 years

Summary

This trial tests NAC and corticosteroids for lung cancer patients with ILD planning radiation therapy.

Who is the study for?

This trial is for adults with lung cancer or up to two small lung tumors and Interstitial Lung Disease (ILD), who are set for radiation therapy. They should be relatively active, have a life expectancy over 6 months, and may continue their ILD treatments like nintedanib or corticosteroids. People can't join if they're allergic to N-Acetyl cysteine or dexamethasone, pregnant, previously had lung radiotherapy, or have certain medical conditions.

What is being tested?

The study tests whether adding oral N-acetylcysteine (NAC) or short-term corticosteroids reduces respiratory symptoms in patients receiving radiation therapy for lung cancer with ILD. It's a double-blind trial where patients randomly get either the real drugs or placebos alongside their standard treatment.

What are the potential side effects?

Possible side effects include allergic reactions to NAC or dexamethasone, increased risk of infection from steroids, blood sugar changes, mood swings, stomach issues from NAC and potential worsening of pre-existing conditions like glaucoma due to steroid use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have lung cancer or 1-2 small lung tumors and will receive high-dose radiation.

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I have been diagnosed with a type of lung scarring disease by a lung specialist.

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I can care for myself but may not be able to do heavy physical work.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had radiation therapy for my lung before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Cancer Specific Survival

Local Control as Determined by Radiographic Evidence

Overall Survival

+5 more

Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: NAC + Dexamethasone PlaceboActive Control3 Interventions

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.

Group II: NAC + CorticosteroidsActive Control3 Interventions

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.

Group III: Corticosteroids + NAC PlaceboActive Control3 Interventions

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.

Group IV: NAC Placebo + Dexamethasone PlaceboPlacebo Group3 Interventions

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.

0 / 5Eligibility criteria met