Endobronchial Cryotherapy in Management of MEBO in Patients With Inoperable NSCLC

Non Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04710459
• Other study ID #: SVU-MED-84-10-12-2016
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: May 2019

Study information

• Verified date: March 2021
• Source: South Valley University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2019
• Est. primary completion date: April 2019
• Gender: All
• Age group: 47 Years to 71 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Procedure:
• cryotherapy
Group 1 included 30 patients, they were subjected to chemoradiotherapy plus endobronchial cryotherapy. Group 2 included include 30 patients, they were subjected to chemoradiotherapy.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mohamed Abdel Bary Ahmed Ibrahim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.