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

Phase 2

Waitlist Available

Research Sponsored by Lawson Health Research Institute

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9 years

Awards & highlights

RESPIRE-ILD Trial 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.Check my eligibility

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.See study design

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.

RESPIRE-ILD Trial 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.

RESPIRE-ILD Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of Grade 2-5 Dyspnea within 6 Months Post Radiation Measured by the Common Terminology Criteria for Adverse Events (CTCAE) Version 5

Secondary outcome measures

Cancer Specific Survival

Local Control as Determined by Radiographic Evidence

Overall Survival

+8 more

RESPIRE-ILD 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: 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 III: 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 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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Centre Hospitalier de l'Universite de Montreal (CHUM)UNKNOWN

Lawson Health Research InstituteLead Sponsor

656 Previous Clinical Trials

413,330 Total Patients Enrolled

London Health Sciences CentreOTHER

142 Previous Clinical Trials

49,820 Total Patients Enrolled

Media Library

NAC + Corticosteroids Clinical Trial Eligibility Overview. Trial Name: NCT05986318 — Phase 2

Interstitial Lung Disease Research Study Groups: NAC + Dexamethasone Placebo, Corticosteroids + NAC Placebo, NAC + Corticosteroids, NAC Placebo + Dexamethasone Placebo

Interstitial Lung Disease Clinical Trial 2023: NAC + Corticosteroids Highlights & Side Effects. Trial Name: NCT05986318 — Phase 2

NAC + Corticosteroids 2023 Treatment Timeline for Medical Study. Trial Name: NCT05986318 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the NAC + Corticosteroids combination been authorized by the FDA?

"Our team has evaluated the safety of NAC + Corticosteroids and assigned it a score of 2 due to its Phase 2 status, indicating that there is some evidence behind its safety but none attesting to efficacy."

Answered by AI

Is this research endeavor currently welcoming participants?

"The clinical trial registry on clinicialtrials.gov states that this particular medical study, posted December 1st 2023 and updated August 1st 2023, is not currently seeking new candidates. However, there are numerous other trials actively recruiting across the globe at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Reducing Respiratory Symptoms of Pulmonary Irradiation in Interstitial Lung Disease

David Palma 2024. "Reducing Respiratory Symptoms of Pulmonary Irradiation in Interstitial Lung Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05986318.

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