Testing N-Acetyl cysteine against a placebo for lung cancer
Official title: Reducing Respiratory Symptoms of Pulmonary Irradiation in Interstitial Lung Disease
Reducing Respiratory Symptoms of Pulmonary Irradiation in Interstitial Lung Disease: A 2x2 Factorial Randomized Phase II Trial Testing N-Acetyl Cysteine and Dexamethasone
- Phase 2
- 4 groups
- Sites in Vancouver, Saint John and 2 more cities
- Recruiting
Interventions (5)
- Other intervention
N-Acetyl cysteine
NAC capsules
- Medication
Dexamethasone Oral
Dexamethasone tablets
- Other intervention
N-Acetyl cysteine Placebo
Matching placebo for NAC capsules
- Medication
Dexamethasone Placebo
Matching placebo for dexamethasone tablets
- Radiation therapy
Radiation Therapy
All participants will receive radical pulmonary radiation therapy. Conventional techniques or stereotactic ablative radiotherapy will be used.
Canadian Sites (4)
4 of 4 recruiting
- Recruiting
BC-Cancer Agency - Vancouver
Vancouver, British Columbia
- Recruiting
Saint John Regional Hospital-Horizon Health Network
Saint John, New Brunswick
- Recruiting
Verspeeten Family Cancer Centre, London Health Sciences Centre
London, Ontario
- Recruiting
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec
Eligibility Criteria
See who this study is looking for29 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Lung cancer or 1-2 oligometastatic pulmonary lesions planned for radical intent radiotherapy \[minimal Biologically Effective Does (BED) of 48 Gy10 (Gray) or biological equivalent\].
- +Eastern Cooperative Oncology Group (ECOG) performance status 0-3
- +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
- +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
- −Previous intolerance or allergy to dexamethasone or NAC
- −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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, preclude radiotherapy or prevent follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → after radiotherapy
- −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
- −Male participants should use adequate forms of birth controlControl groupThe group a new treatment is measured against.Read more → with their partners.
- −Current or recent use of NAC
- −Contraindications to dexamethasone or N-Acetyl Cysteine (NAC). These include:
- −Scleroderma
- −Active infection
- −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
- −If not pregnant, use of effective contraception methods for women of childbearing age is required which can include:
- −Women who become pregnant should stop taking NAC and/or dexamethasone and inform their study doctor.
- −Currently breastfeeding
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 4 groups in this study.
Group A, the comparison group, receives one or more of: N-Acetyl cysteine, Dexamethasone Oral and Radiation Therapy.
Registry label: A: NAC + Corticosteroids
Group B, the comparison group, receives one or more of: Dexamethasone Oral, N-Acetyl cysteine PlaceboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → and Radiation Therapy.
Registry label: B: Corticosteroids + NAC Placebo
Group C, the comparison group, receives Dexamethasone Placebo, together with one or more of: N-Acetyl cysteine and Radiation Therapy.
Registry label: C: NAC + Dexamethasone Placebo
Group D, the placebo group, receives Dexamethasone Placebo, together with one or more of: N-Acetyl cysteine Placebo and Radiation Therapy.
Registry label: D: NAC Placebo + Dexamethasone Placebo
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
Neither you nor the study team would know which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 98 people.
The study is currently expected to finish around December 2032.
The main measurement is taken over: Up to 6 months post radiation therapy.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Rate of Grade 2-5 Dyspnea within 6 Months Post Radiation Measured by the Common Terminology Criteria for Adverse EventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (CTCAE) Version 5 — measured over Up to 6 months post radiation therapy.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05986318 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About N-Acetyl cysteineDietary supplement
NAC capsules
From the trial registry — its own words, unedited.
What a dietary supplement is here: A vitamin, mineral, or other supplement being studied.
Read the full explanation → · in clinical review
About Dexamethasone OralDrug
Dexamethasone tablets
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About N-Acetyl cysteine PlaceboDietary supplement
Matching placebo for NAC capsules
From the trial registry — its own words, unedited.
What a dietary supplement is here: A vitamin, mineral, or other supplement being studied.
Read the full explanation → · in clinical review
About Dexamethasone PlaceboDrug
Matching placebo for dexamethasone tablets
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Radiation TherapyRadiation
All participants will receive radical pulmonary radiation therapy. Conventional techniques or stereotactic ablative radiotherapy will be used.
From the trial registry — its own words, unedited.
What a radiation is here: A form of radiotherapy or radiation-based treatment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
Neither you nor the study team would know which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to 6 months post radiation therapy.
The study as a whole is currently expected to finish around 2032-12-31.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 98 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 4 locations, including: Vancouver, British Columbia, Canada; Saint John, New Brunswick, Canada; London, Ontario, Canada; Montreal, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.