Endobronchial Cryotherapy in Management of MEBO in Patients With Inoperable NSCLC

Study Overview
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Brief Summary
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Background: In end-stage patients when all management options have been used, will often develop compromise of their airways as the cancer continues to progress. Endobronchial therapy options may help to relieve some of their symptoms, allowing improvement in their shortness of breath as they go home in combination with other palliative therapies. Objective: to compare the safety ; efficacy; and clinical outcome of endobronchial cryotherapy combined with chemotherapy and/ or radiotherapy versus chemo-radiotherapy alone on patients with Non small cell lung cancer. Patients and method(s): A prospective randomized clinical trial was carried out on 60 patients with different ages of both sexes, diagnosed as bronchogenic carcinoma non-small cell lung cancer type (NSCLC) . The patients attended the hospital in the chest department, Qena Faculty of Medicine, South Valley University. Assessment of the patients was done and randomly assigned into two groups. Group1 ,Include 30 patients subjected to chemotherapy , radiotherapy and endobronchial cryotherapy.Group 2 , Include include 30 patients subjected to chemotherapy and radiotherapy alone.

Official Title
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The Value of Endobronchial Cryotherapy in the Management of Malignant Endobronchial Obstruction in Patients With Inoperable NSCLC: A Prospective Analysis of Clinical and Survival Outcomes

Conditions
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Non Small Cell Lung Cancer, Non-Small Cell Carcinoma of Lung, TNM Stage 4, Bronchogenic Cancer

Intervention / Treatment
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* Procedure: cryotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All cases with pathologically proved and inoperable NSCLC cases based on tumor position; in the main and subsegmental bronchi. Exclusion Criteria: Cases with severe respiratory distress, uncorrectable impaired bleeding profile and prechemotherapy.

Ages Eligible for Study
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Minimum Age: 47 Years
Maximum Age: 71 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>it included 30 patients, they were subjected to chemoradiotherapy plus endobronchial cryotherapy. | Procedure: cryotherapy<br>* Group 1 included 30 patients, they were subjected to chemoradiotherapy plus endobronchial cryotherapy. Group 2 included include 30 patients, they were subjected to chemoradiotherapy.<br>|
| No Intervention: Group 2<br>it included include 30 patients, they were subjected to chemoradiotherapy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the clinical changes of the cases after procedure. | Evaluation of the rate of symptoms relief after therapy | the symptoms were evaluated before therapy as a baseline; and evaluated 4 weeks after procedure. | 
| Respiratory function test evaluation | Spirometry was done (FEV1 in %, FVC in %, FEV1/FVC in %). | Change from Baseline Spirometry done before management, was compared with that was done at 4 weeks after management. | 
| Assessment of the overall survival | Assessment of the overall survival was done by Kaplan-Meier method | The overall survival was measured by the percentage of patients who still alive for 12 months after they were started the management. | 
| Assessment of the performance status | It was performed using the mean Karnofsky performance score | The mean Karnofsky performance score was done before treatment as a baseline; and 4 weeks after treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial blood gases evaluation | It included; Mean So2 (mm Hg), Mean PaO2 (mmHg), Mean PaCo2 (mm Hg). | Arterial blood gases was done before treatment as a baseline; and 4 weeks after treatment. | 
| Six minute walk distance test | Six minute walk distance test was measured in minutes | Six minute walk test was done before treatment as a baseline; and 4 weeks after treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-small cell lung cancer (NSCLC), Cryotherapy, Chemoradiotherapy