Reducing Respiratory Symptoms of Pulmonary Irradiation in Interstitial Lung Disease
NCT ID: NCT05986318
Last Updated: 2025-12-04
Study Results
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Basic Information
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RECRUITING
PHASE2
98 participants
INTERVENTIONAL
2025-01-07
2032-12-31
Brief Summary
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Detailed Description
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Patients with Interstitial Lung Disease (ILD) are at increased risk of developing lung cancer compared to the general population. Management of patients with lung cancer in the setting of a concomitant ILD is complex, as these patients are usually not good candidates for surgery or immunotherapy. In addition, patients with ILD, particularly fibrotic ILD, are also reportedly at increased risk of treatment-related toxicity from RT.
In the present study, investigators will test the following hypotheses:
1. The use of NAC with RT in patients with underlying ILD will lead to a clinically meaningful reduction in grade 2-5 dyspnea (as per Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0).
2. The use of corticosteroids with RT in patients with underlying ILD will lead to a clinically meaningful reduction in grade 2-5 dyspnea (as per CTCAE version 5.0).
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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NAC + Corticosteroids
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.
N-Acetyl cysteine
NAC capsules
Dexamethasone Oral
Dexamethasone tablets
Radiation Therapy
All participants will receive radical pulmonary radiation therapy. Conventional techniques or stereotactic ablative radiotherapy will be used.
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.
Participants will also take matching NAC placebo orally, three times daily, for 60 days.
All participants will be treated with radical pulmonary radiation therapy.
Dexamethasone Oral
Dexamethasone tablets
N-Acetyl cysteine Placebo
Matching placebo for NAC capsules
Radiation Therapy
All participants will receive radical pulmonary radiation therapy. Conventional techniques or stereotactic ablative radiotherapy will be used.
NAC + Dexamethasone Placebo
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.
N-Acetyl cysteine
NAC capsules
Dexamethasone Placebo
Matching placebo for dexamethasone tablets
Radiation Therapy
All participants will receive radical pulmonary radiation therapy. Conventional techniques or stereotactic ablative radiotherapy will be used.
NAC Placebo + Dexamethasone Placebo
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.
N-Acetyl cysteine Placebo
Matching placebo for NAC capsules
Dexamethasone Placebo
Matching placebo for dexamethasone tablets
Radiation Therapy
All participants will receive radical pulmonary radiation therapy. Conventional techniques or stereotactic ablative radiotherapy will be used.
Interventions
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N-Acetyl cysteine
NAC capsules
Dexamethasone Oral
Dexamethasone tablets
N-Acetyl cysteine Placebo
Matching placebo for NAC capsules
Dexamethasone Placebo
Matching placebo for dexamethasone tablets
Radiation Therapy
All participants will receive radical pulmonary radiation therapy. Conventional techniques or stereotactic ablative radiotherapy will be used.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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London Health Sciences Centre
OTHER
Centre Hospitalier de l'Universite de Montreal (CHUM)
UNKNOWN
David Palma
OTHER
Responsible Party
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David Palma
Principal Investigator
Principal Investigators
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David Palma, MD
Role: STUDY_CHAIR
London Health Sciences Centre, Lawson Health Research Institute
Houda Bahig, MD
Role: STUDY_CHAIR
Centre Hospitalier de l'Universite de Montreal
Locations
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London Regional Cancer Program, London Health Sciences Centre
London, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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Verstegen NE, Lagerwaard FJ, Hashemi SM, Dahele M, Slotman BJ, Senan S. Patterns of Disease Recurrence after SABR for Early Stage Non-Small-Cell Lung Cancer: Optimizing Follow-Up Schedules for Salvage Therapy. J Thorac Oncol. 2015 Aug;10(8):1195-200. doi: 10.1097/JTO.0000000000000576.
Choi YW, Munden RF, Erasmus JJ, Park KJ, Chung WK, Jeon SC, Park CK. Effects of radiation therapy on the lung: radiologic appearances and differential diagnosis. Radiographics. 2004 Jul-Aug;24(4):985-97; discussion 998. doi: 10.1148/rg.244035160.
Kainthola A, Haritwal T, Tiwari M, Gupta N, Parvez S, Tiwari M, Prakash H, Agrawala PK. Immunological Aspect of Radiation-Induced Pneumonitis, Current Treatment Strategies, and Future Prospects. Front Immunol. 2017 May 2;8:506. doi: 10.3389/fimmu.2017.00506. eCollection 2017.
Tsoutsou PG, Koukourakis MI. Radiation pneumonitis and fibrosis: mechanisms underlying its pathogenesis and implications for future research. Int J Radiat Oncol Biol Phys. 2006 Dec 1;66(5):1281-93. doi: 10.1016/j.ijrobp.2006.08.058.
Niska JR, Schild SE, Rule WG, Daniels TB, Jett JR. Fatal Radiation Pneumonitis in Patients With Subclinical Interstitial Lung Disease. Clin Lung Cancer. 2018 Jul;19(4):e417-e420. doi: 10.1016/j.cllc.2018.02.003. Epub 2018 Feb 17. No abstract available.
Axelsson GT, Putman RK, Aspelund T, Gudmundsson EF, Hida T, Araki T, Nishino M, Hatabu H, Gudnason V, Hunninghake GM, Gudmundsson G. The associations of interstitial lung abnormalities with cancer diagnoses and mortality. Eur Respir J. 2020 Dec 17;56(6):1902154. doi: 10.1183/13993003.02154-2019. Print 2020 Dec.
Ozawa Y, Abe T, Omae M, Matsui T, Kato M, Hasegawa H, Enomoto Y, Ishihara T, Inui N, Yamada K, Yokomura K, Suda T. Impact of Preexisting Interstitial Lung Disease on Acute, Extensive Radiation Pneumonitis: Retrospective Analysis of Patients with Lung Cancer. PLoS One. 2015 Oct 13;10(10):e0140437. doi: 10.1371/journal.pone.0140437. eCollection 2015.
Sanuki N, Ono A, Komatsu E, Kamei N, Akamine S, Yamazaki T, Mizunoe S, Maeda T. Association of computed tomography-detected pulmonary interstitial changes with severe radiation pneumonitis for patients treated with thoracic radiotherapy. J Radiat Res. 2012;53(1):110-6. doi: 10.1269/jrr.110142.
Makimoto T, Tsuchiya S, Hayakawa K, Saitoh R, Mori M. Risk factors for severe radiation pneumonitis in lung cancer. Jpn J Clin Oncol. 1999 Apr;29(4):192-7. doi: 10.1093/jjco/29.4.192.
Lee YH, Kim YS, Lee SN, Lee HC, Oh SJ, Kim SJ, Kim YK, Han DH, Yoo IeR, Kang JH, Hong SH. Interstitial Lung Change in Pre-radiation Therapy Computed Tomography Is a Risk Factor for Severe Radiation Pneumonitis. Cancer Res Treat. 2015 Oct;47(4):676-86. doi: 10.4143/crt.2014.180. Epub 2015 Feb 13.
Yamaguchi S, Ohguri T, Matsuki Y, Yahara K, Oki H, Imada H, Narisada H, Korogi Y. Radiotherapy for thoracic tumors: association between subclinical interstitial lung disease and fatal radiation pneumonitis. Int J Clin Oncol. 2015 Feb;20(1):45-52. doi: 10.1007/s10147-014-0679-1. Epub 2014 Mar 11.
Other Identifiers
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RESPIRE-ILD
Identifier Type: -
Identifier Source: org_study_id
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