Prophylactic Inhaled Steroids to Reduce Radiation Pneumonitis Frequency and Severity in Lung Cancer Patients

NCT03803787 | Recruiting Phase 2 DMC

• 1 other identifier: CI/910/17
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief Summary

This randomized clinical study aims to assess whether prophylactic treatment with inhaled steroids in patients with locally advanced or concomitantly treated non-small cell lung carcinoma who are candidates for combination treatment with QT/RT or IMT + QT/RT. The main questions it aims to answer are: Whether prophylactic treatment decreases the severity of NPR on CTCAE v4.0 and RTOG scales. Whether inhaled steroid use modifies the response to radiation therapy treatment compared to patients who do not receive prophylactic inhaled steroids.

Conditions

Radiation Pneumonitis

Keywords

Non-Small Cell Lung Cancer; Radiation Pneumonia; Lung cancer treatment; Respiratory Tract Neoplasms; Radiation fibrosis; Thoracic Neoplasms; Lung Diseases; Radiation Injury with Fibrosis; Radiation Fibrosis of Lung; Lung Injury

Outcome Measures

Primary Outcomes (2)

• Pneumonitis graded by the Common terminology criteria for adverse event v4.0. (CTCAE v4.0).

  Current score for radiation pneumonitis according to symptoms and radiographic changes. Grade 0: No changes, Grade 1: Asymptomatic or mild respiratory symptoms, Grade 2: Moderate respiratory symptoms of pneumonitis (a severe cough) and radiographic changes (radiographic patches), Grade 3: Severe respiratory symptoms of pneumonitis, dense radiographic changes. Grade 4: Symptoms of acute respiratory failure requiring assisted ventilation or continuous oxygen. Grade 5: Death directly related to late effects of radiotherapy.

  from the beginning of radiotherapy up to 1 year after the 1st session.

• Pneumonitis graded by the Radiation Therapy Oncology Group score (RTOG)

  Current score for radiation pneumonitis according to symptoms and radiographic changes. Grade 0: No changes, Grade 1: Asymptomatic, only radiological or tomographic findings, Grade 2: Symptomatic, does not interfere with daily activities, Grade 3: Symptomatic, interferes with daily activities, requires supplemental oxygen. Grade 4: Threatens life, needing ventilator support. Grade 5: Severe pneumonitis with fatal outcome.

  from the beginning of radiotherapy up to 1 year after the 1st session.

Secondary Outcomes (13)

• Lung cancer-associated symptoms assessment

  before the start of Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment.

• Treatment-related side effects in lung cancer

  before the start of Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment.

• Cognitive functioning evaluated by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire

  before the start of Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment.

• Emotional Functioning evaluated by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire

  before the start Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment

• Physical functioning evaluated by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire

  before the start Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment.

Study Arms (4)

QT/RT + Budesonide

EXPERIMENTAL

Patients are receiving chemotherapy (QT) and radiotherapy (RT) plus inhaled Budesonide with space chamber at 400 mcg given twice daily initiating after the first dose of RT and continuing until pneumonitis development or 12 months completed.

Drug: Inhaled budesonide

QT/RT + No medication

NO INTERVENTION

Patients are receiving chemotherapy (QT) and radiotherapy (RT) without intervention therapy and followed during 12 months.

Target drug/RT + Budesonide

EXPERIMENTAL

Patients are receiving target therapy and radiotherapy (RT) plus inhaled Budesonide with space chamber at 400 mcg given twice daily initiating after the first dose of RT and continuing until pneumonitis development or 12 months completed.

Drug: Inhaled budesonide

Target drug/RT + No medication

NO INTERVENTION

Patients are receiving target treatment and radiotherapy (RT) without intervention therapy and followed during 12 months.

Interventions

Inhaled budesonide DRUG

Patients will use inhaled budesonide (Numark) with space chamber at 400 mcg given twice daily initiating after the first dose of RT and continuing until pneumonitis development or 12 months completed.

Also known as: Numark

QT/RT + Budesonide; Target drug/RT + Budesonide

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with non-small cell lung cancer (NSCLC) with unresectable locally advanced or metastatic disease (IIIA, IIIB or IV) of the classification tumor node, metastasis (TNM) of malignant lung tumors, 7th edition.
• NSCLC patients candidates for concomitant treatment (chemotherapy plus radiotherapy or target therapy plus radiotherapy).
• Evidence of measurable disease
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2, Karnofsky 70-100.
• Life expectancy of \> 4 months at the time of screening
• Patients with the ability to comply with the study and follow-up procedures.
• Patients with previous surgery less than four weeks.
• Must be willing and able to give signed informed consent and, in the opinion of the Investigator, to comply with the protocol tests and procedures.

You may not qualify if:

• Unstable systemic disease: active infection, heart, liver, kidney or metabolic disease; including uncontrolled chronic lung disease.
• Patients treated with systemic or inhaled corticosteroids.
• Patients of reproductive age without a family planning method, pregnant or lactating.
• Previous diagnosis of Pneumonitis with toxicity grade ≥ 2 by CTCAE v4.0 or RTOG scale.
• Patients with disease progression.
• Inspiratory flow \< 90 liters / min.
• Discontinue of Treatment

Sponsors & Collaborators

• Instituto Nacional de Cancerologia de Mexico: lead
• Instituto Nacional de Enfermedades Respiratorias: collaborator

Study Sites (2)

Instituto Nacional de Cancerologia

Mexico City, 14080, Mexico

RECRUITING

Instituto Nacional de Enfermedades Respiratorias

Mexico City, 14080, Mexico

ACTIVE NOT RECRUITING

Related Publications (11)

• Arrieta O, Guzman-de Alba E, Alba-Lopez LF, Acosta-Espinoza A, Alatorre-Alexander J, Alexander-Meza JF, Allende-Perez SR, Alvarado-Aguilar S, Araujo-Navarrete ME, Argote-Greene LM, Aquino-Mendoza CA, Astorga-Ramos AM, Austudillo-de la Vega H, Aviles-Salas A, Barajas-Figueroa LJ, Barroso-Quiroga N, Blake-Cerda M, Cabrera-Galeana PA, Calderillo-Ruiz G, Campos-Parra AD, Cano-Valdez AM, Capdeville-Garcia D, Castillo-Ortega G, Casillas-Suarez C, Castillo-Gonzalez P, Corona-Cruz JF, Correa-Acevedo ME, Cortez-Ramirez SS, de la Cruz-Vargas JA, de la Garza-Salazar JG, de la Mata-Moya MD, Dominguez-Flores ME, Dominguez-Malagon HR, Dominguez-Parra LM, Dominguez-Peregrina A, Duran-Alcocer J, Enriquez-Aceves MI, Elizondo-Rios A, Escobedo-Sanchez MD, de Villafranca PE, Flores-Cantisani A, Flores-Gutierrez JP, Franco-Marina F, Franco-Gonzalez EE, Franco-Topete RA, Fuentes-de la Pena H, Galicia-Amor S, Gallardo-Rincon D, Gamboa-Dominguez A, Garcia-Andreu J, Garcia-Cuellar CM, Garcia-Sancho-Figueroa MC, Garcia-Torrentera R, Gerson-Cwilich R, Gomez-Gonzalez A, Green-Schneeweiss L, Guillen-Nunez Mdel R, Gutierrez-Velazquez H, Ibarra-Perez C, Jimenez-Fuentes E, Juarez-Sanchez P, Juarez-Ramiro A, Kelly-Garcia J, Kuri-Exsome R, Lazaro-Leon JM, Leon-Rodriguez E, Llanos-Osuna S, Llanos-Osuna S, Loyola-Garcia U, Lopez-Gonzalez JS, Lopez y de Antunano FJ, Loustaunau-Andrade MA, Macedo-Perez EO, Machado-Villarroel L, Magallanes-Maciel M, Martinez-Barrera L, Martinez-Cedillo J, Martinez-Martinez G, Medina-Esparza A, Meneses-Garcia A, Mohar-Betancourt A, Morales Blanhir J, Morales-Gomez J, Motola-Kuba D, Najera-Cruz MP, Nunez-Valencia Cdel C, Ocampo-Ocampo MA, Ochoa-Vazquez MD, Olivares-Torres CA, Palomar-Lever A, Patino-Zarco M, Perez-Padilla R, Pena-Alonso YR, Perez-Romo AR, Aquilino Perez M, Pinaya-Ruiz PM, Pointevin-Chacon MA, Poot-Braga JJ, Posadas-Valay R, Ramirez-Marquez M, Reyes-Martinez I, Robledo-Pascual J, Rodriguez-Cid J, Rojas-Marin CE, Romero-Bielma E, Rubio-Gutierrez JE, Saenz-Frias JA, Salazar-Lezama MA, Sanchez-Lara K, Sansores Martinez R, Santillan-Doherty P, Alejandro-Silva J, Tellez-Becerra JL, Toledo-Buenrostro V, Torre-Bouscoulet L, Torecillas-Torres L, Torres M, Tovar-Guzman V, Turcott-Chaparro JG, Vazquez-Cortes JJ, Vazquez-Manriquez ME, Vilches-Cisneros N, Villegas-Elizondo JF, Zamboni MM, Zamora-Moreno J, Zinser-Sierra JW. [National consensus of diagnosis and treatment of non-small cell lung cancer]. Rev Invest Clin. 2013 Mar;65 Suppl 1:S5-84. Spanish.

  PMID: 24459776 RESULT

• Timmerman R, McGarry R, Yiannoutsos C, Papiez L, Tudor K, DeLuca J, Ewing M, Abdulrahman R, DesRosiers C, Williams M, Fletcher J. Excessive toxicity when treating central tumors in a phase II study of stereotactic body radiation therapy for medically inoperable early-stage lung cancer. J Clin Oncol. 2006 Oct 20;24(30):4833-9. doi: 10.1200/JCO.2006.07.5937.

  PMID: 17050868 RESULT

• Henkenberens C, Janssen S, Lavae-Mokhtari M, Leni K, Meyer A, Christiansen H, Bremer M, Dickgreber N. Inhalative steroids as an individual treatment in symptomatic lung cancer patients with radiation pneumonitis grade II after radiotherapy - a single-centre experience. Radiat Oncol. 2016 Feb 2;11:12. doi: 10.1186/s13014-016-0580-3.

  PMID: 26830686 RESULT

• Kim S, Oh IJ, Park SY, Song JH, Seon HJ, Kim YH, Yoon SH, Yu JY, Lee BR, Kim KS, Kim YC. Corticosteroid therapy against treatment-related pulmonary toxicities in patients with lung cancer. J Thorac Dis. 2014 Sep;6(9):1209-17. doi: 10.3978/j.issn.2072-1439.2014.07.16.

  PMID: 25276362 RESULT

• Ding NH, Li JJ, Sun LQ. Molecular mechanisms and treatment of radiation-induced lung fibrosis. Curr Drug Targets. 2013 Oct;14(11):1347-56. doi: 10.2174/13894501113149990198.

  PMID: 23909719 RESULT

• Williams JP, Johnston CJ, Finkelstein JN. Treatment for radiation-induced pulmonary late effects: spoiled for choice or looking in the wrong direction? Curr Drug Targets. 2010 Nov;11(11):1386-94. doi: 10.2174/1389450111009011386.

  PMID: 20583979 RESULT

• Daley-Yates PT. Inhaled corticosteroids: potency, dose equivalence and therapeutic index. Br J Clin Pharmacol. 2015 Sep;80(3):372-80. doi: 10.1111/bcp.12637. Epub 2015 May 28.

  PMID: 25808113 RESULT

• Leach C, Colice GL, Luskin A. Particle size of inhaled corticosteroids: does it matter? J Allergy Clin Immunol. 2009 Dec;124(6 Suppl):S88-93. doi: 10.1016/j.jaci.2009.09.050.

  PMID: 19962042 RESULT

• Bledsoe TJ, Nath SK, Decker RH. Radiation Pneumonitis. Clin Chest Med. 2017 Jun;38(2):201-208. doi: 10.1016/j.ccm.2016.12.004. Epub 2017 Mar 1.

  PMID: 28477633 RESULT

• Simone CB 2nd. Thoracic Radiation Normal Tissue Injury. Semin Radiat Oncol. 2017 Oct;27(4):370-377. doi: 10.1016/j.semradonc.2017.04.009.

  PMID: 28865520 RESULT

• Vallard A, Rancoule C, Le Floch H, Guy JB, Espenel S, Le Pechoux C, Deutsch E, Magne N, Chargari C. [Medical prevention and treatment of radiation-induced pulmonary complications]. Cancer Radiother. 2017 Aug;21(5):411-423. doi: 10.1016/j.canrad.2017.03.004. Epub 2017 Jun 5. French.

  PMID: 28596060 RESULT

MeSH Terms

Conditions

Radiation Pneumonitis; Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms; Radiation Fibrosis Syndrome; Thoracic Neoplasms; Lung Diseases; Lung Injury

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Respiratory Tract Diseases; Radiation Injuries; Wounds and Injuries; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Neoplasms by Site; Neoplasms; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Thoracic Injuries

Study Officials

• Oscar Arrieta, MD MSc

  Instituto Nacional de Cancerologia, Mexico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oscar Arrieta, MD MSc

CONTACT

015556280400; ogarrieta@gmail.com

Diana Flores

CONTACT

015556280400; clinicacancerpulmonincan@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Thoracic Oncology unit

Study Record Dates

• First Submitted: January 3, 2019
• First Posted: January 15, 2019
• Study Start: September 1, 2018
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: october 2021
• Access Criteria: the information will be available after being published in an indexed journal, any information or data related to this study must be requested via e-mail with the researchers.

Locations

ME (2)