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Simple drugs may ease radiation breathing woes for lung patients

NCT ID NCT05986318

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 2 times

Summary

This study tests whether N-acetyl cysteine (NAC) and a short course of steroids can reduce severe shortness of breath after lung radiation in people with both lung cancer and interstitial lung disease. About 98 participants will receive either NAC or placebo, plus either steroids or placebo, for a short time. The goal is to see if these drugs can make breathing easier after treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 98 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Dec 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • BC-Cancer Agency - Vancouver

    RECRUITING

    Vancouver, British Columbia, V5Z 4E6, Canada

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

    RECRUITING

    Montreal, Quebec, H2X 0A9, Canada

  • Saint John Regional Hospital-Horizon Health Network

    RECRUITING

    Saint John, New Brunswick, E2L4L2, Canada

  • Verspeeten Family Cancer Centre, London Health Sciences Centre

    RECRUITING

    London, Ontario, N6A 5W9, Canada

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