[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100515039":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":64,"centralContacts":72,"locations":80,"responsibleParty":142,"collaborators":146,"id":151,"slug":152,"hasResults":153,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":153,"sex":159,"minAge":160,"maxAge":63,"enrollmentInfo":161,"targetDuration":63,"studyType":164,"phases":165,"briefSummary":167,"conditions":168,"keywords":171,"overallStatus":83,"whyStopped":63,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":185},{"fullName":5,"class":6},"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's","OTHER",[8,16,21,26],{"label":9,"type":10,"description":11,"interventionNames":12},"NAC + Corticosteroids","ACTIVE_COMPARATOR","Participants will take 600 mg of active NAC orally, three times daily, for 60 days.\n\nParticipants 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.\n\nAll participants will be treated with radical pulmonary radiation therapy.",[13,14,15],"Dietary Supplement: N-Acetyl cysteine","Drug: Dexamethasone Oral","Radiation: Radiation Therapy",{"label":17,"type":10,"description":18,"interventionNames":19},"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.\n\nParticipants will also take matching NAC placebo orally, three times daily, for 60 days.\n\nAll participants will be treated with radical pulmonary radiation therapy.",[14,20,15],"Dietary Supplement: N-Acetyl cysteine Placebo",{"label":22,"type":10,"description":23,"interventionNames":24},"NAC + Dexamethasone Placebo","Participants will take 600 mg of active NAC orally, three times daily, for 60 days.\n\nParticipants 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.\n\nAll participants will be treated with radical pulmonary radiation therapy.",[13,25,15],"Drug: Dexamethasone Placebo",{"label":27,"type":28,"description":29,"interventionNames":30},"NAC Placebo + Dexamethasone Placebo","PLACEBO_COMPARATOR","Participants will take matching NAC placebo orally, three times daily, for 60 days.\n\nParticipants 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.\n\nAll participants will be treated with radical pulmonary radiation therapy.",[20,25,15],[32,39,46,52,58],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"DIETARY_SUPPLEMENT","N-Acetyl cysteine","NAC capsules",[9,22],[38],"NAC",{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"DRUG","Dexamethasone Oral","Dexamethasone tablets",[17,9],[45],"Corticosteroid",{"type":33,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"N-Acetyl cysteine Placebo","Matching placebo for NAC capsules",[17,27],[51],"NAC Placebo",{"type":40,"name":53,"description":54,"armGroupLabels":55,"otherNames":56},"Dexamethasone Placebo","Matching placebo for dexamethasone tablets",[22,27],[57],"Corticosteroid Placebo",{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":63},"RADIATION","Radiation Therapy","All participants will receive radical pulmonary radiation therapy. Conventional techniques or stereotactic ablative radiotherapy will be used.",[17,9,22,27],null,[65,69],{"name":66,"affiliation":67,"role":68},"David Palma, MD","London Health Sciences Centre, Lawson Health Research Institute","STUDY_CHAIR",{"name":70,"affiliation":71,"role":68},"Houda Bahig, MD","Centre Hospitalier de l'Universite de Montreal",[73,77],{"name":66,"role":74,"phone":75,"phoneExt":63,"email":76},"CONTACT","519-685-8650","david.palma@lhsc.on.ca",{"name":70,"role":74,"phone":78,"phoneExt":63,"email":79},"514-890-8254","houda.bahig.chum@ssss.gouv.qc.ca",[81,108,121],{"facility":82,"status":83,"city":84,"state":85,"zip":86,"country":87,"countryCode":88,"cosmosGeoPoint":89,"geoPoint":94,"contacts":95},"BC-Cancer Agency - Vancouver","RECRUITING","Vancouver","British Columbia","V5Z 4E6","Canada","CA",{"type":90,"coordinates":91},"Point",[92,93],-123.11934,49.24966,{"lat":93,"lon":92},[96,101,105],{"name":97,"role":74,"phone":98,"phoneExt":99,"email":100},"Sijia (Jackie) Cao, CCRP","604-877-6000","672683","sijia.cao@bccancer.bc.ca",{"name":102,"role":74,"phone":98,"phoneExt":103,"email":104},"Fermin Hoq","675076","fermin.hoq1@bccancer.bc.ca",{"name":106,"role":107,"phone":63,"phoneExt":63,"email":63},"Srinivas Raman, MD,FRCPC","PRINCIPAL_INVESTIGATOR",{"facility":109,"status":83,"city":110,"state":111,"zip":112,"country":87,"countryCode":88,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"Verspeeten Family Cancer Centre, London Health Sciences Centre","London","Ontario","N6A 5W9",{"type":90,"coordinates":114},[115,116],-81.23304,42.98339,{"lat":116,"lon":115},[119],{"name":66,"role":74,"phone":75,"phoneExt":63,"email":120},"David.Palma@lhsc.on.ca",{"facility":122,"status":83,"city":123,"state":124,"zip":125,"country":87,"countryCode":88,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Centre Hospitalier de l'Universite de Montreal (CHUM)","Montreal","Quebec","H2X 0A9",{"type":90,"coordinates":127},[128,129],-73.58781,45.50884,{"lat":129,"lon":128},[132,137,141],{"name":133,"role":74,"phone":134,"phoneExt":135,"email":136},"Mom Phat","514-890-8000","11171","mom.phat.chum@ssss.gouv.qc.ca",{"name":138,"role":74,"phone":134,"phoneExt":139,"email":140},"Siew Siew Pan","22766","siew.siew.pan.chum@ssss.gouv.qc.ca",{"name":70,"role":107,"phone":63,"phoneExt":63,"email":63},{"type":143,"investigatorFullName":144,"investigatorTitle":145,"investigatorAffiliation":5,"oldNameTitle":63,"oldOrganization":63},"SPONSOR_INVESTIGATOR","David Palma","Principal Investigator",[147,149],{"name":148,"class":6},"London Health Sciences Centre",{"name":150,"class":6},"Centre hospitalier de l'Université de Montréal (CHUM)","100515039","phase-2-reducing-respiratory-symptoms-of-pulmonary-irradiation-in-interstitial-lung-disease-100515039",false,"NCT05986318","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","RESPIRE-ILD","Inclusion Criteria:\n\n* 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\\].\n* Pathologically (histologically or cytologically) proven diagnosis of cancer is not required, but strongly recommended.\n\n  * If the risk of biopsy is unacceptable, pathologic confirmation is not required providing there is growth over time on Computed Tomography (CT) imaging and\u002For Fluorodeoxyglucose (FDG) avidity that is strongly suggestive of malignancy.\n* Fibrotic Interstitial Lung Disease (ILD) of any subtype, as diagnosed by a respirologist and confirmed by central review\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-3\n* Age ≥ 18\n* Life expectancy \\> 6 months\n* 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\u002For 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).\n* 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.\n\nExclusion Criteria:\n\n* Prior lung radiotherapy\n* Current use of oral or intravenous corticosteroids\n* Plans for the patient to receive other local therapy to the target lesion(s) while on this study, except at disease progression\n* Any medical condition that could, in the opinion of the investigator, preclude radiotherapy or prevent follow-up after radiotherapy\n* Pregnancy\n\n  * If not pregnant, use of effective contraception methods for women of childbearing age is required which can include:\n\n    * hormonal methods (e.g. oral, injected, implanted),\n    * placement of an intrauterine device,\n    * barrier methods (i.e. condoms),\n    * sterilization of the partner (e.g. previous vasectomy)\n    * abstinence\n  * Women who become pregnant should stop taking NAC and\u002For dexamethasone and inform their study doctor.\n  * Male participants should use adequate forms of birth control with their partners.\n* Currently breastfeeding\n* Current or recent use of NAC\n* Contraindications to dexamethasone or N-Acetyl Cysteine (NAC). These include:\n\n  * Previous intolerance or allergy to dexamethasone or NAC\n  * Scleroderma\n  * Active infection\n  * Glaucoma\n  * Psychiatric disorder that could be exacerbated by dexamethasone\n  * Cystinuria\n  * Any other condition that the treating physician believes to be a contraindication to dexamethasone or NAC","ALL","18 Years",{"count":162,"type":163},98,"ESTIMATED","INTERVENTIONAL",[166],"PHASE2","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.",[169,170],"Lung Cancer","Interstitial Lung Disease",[172,60,173,174,175],"Pulmonary Irradiation","N-Acetyl Cysteine","Dexamethasone","Radiation Pneumonitis","2026-03-06",{"date":178,"type":179},"2026-03-09","ACTUAL",{"date":181,"type":179},"2025-01-07",{"date":183,"type":163},"2032-12-31",{"name":144,"class":6},3]