Endobronchial Cryotherapy in Management of MEBO in Patients With Inoperable NSCLC

NCT04710459 | Completed DMC

• 1 other identifier: SVU-MED-84-10-12-2016
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Keywords

Non-small cell lung cancer (NSCLC); Cryotherapy; Chemoradiotherapy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Arterial blood gases evaluation

  Arterial blood gases was done before treatment as a baseline; and 4 weeks after treatment.

• Six minute walk distance test

  Six minute walk test was done before treatment as a baseline; and 4 weeks after treatment.

Study Arms (2)

Group 1

ACTIVE COMPARATOR

it included 30 patients, they were subjected to chemoradiotherapy plus endobronchial cryotherapy.

Procedure: cryotherapy

Group 2

NO INTERVENTION

it included include 30 patients, they were subjected to chemoradiotherapy.

Interventions

cryotherapy PROCEDURE

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

Group 1

Eligibility Criteria

• Age: 47 Years - 71 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All cases with pathologically proved and inoperable NSCLC cases based on tumor position; in the main and subsegmental bronchi.

You may not qualify if:

• Cases with severe respiratory distress, uncorrectable impaired bleeding profile and prechemotherapy.

Sponsors & Collaborators

• Mohamed Abdel Bary Ahmed Ibrahim: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: January 14, 2021
• Study Start: December 1, 2016
• Primary Completion: April 1, 2019
• Study Completion: May 1, 2019
• Last Updated: March 8, 2021

Record last verified: 2021-03