Endobronchial Cryotherapy in Management of MEBO in Patients With Inoperable NSCLC

March 4, 2021 updated by: Mohamed Abdel Bary Ahmed Ibrahim

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

47 years to 71 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group 1
it included 30 patients, they were subjected to chemoradiotherapy plus endobronchial cryotherapy.
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.
NO_INTERVENTION: Group 2
it included include 30 patients, they were subjected to chemoradiotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the clinical changes of the cases after procedure.
Time Frame: the symptoms were evaluated before therapy as a baseline; and evaluated 4 weeks 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
Time Frame: Change from Baseline Spirometry done before management, was compared with that was done at 4 weeks after management.
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
Time Frame: 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 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
Time Frame: The mean Karnofsky performance score was done before treatment as a baseline; and 4 weeks after treatment.
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
Time Frame: Arterial blood gases was done before treatment as a baseline; and 4 weeks after treatment.
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
Time Frame: Six minute walk test was done before treatment as a baseline; and 4 weeks after treatment.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mohamed Abdel Bary Ahmed Ibrahim

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2016

Primary Completion (ACTUAL)

April 1, 2019

Study Completion (ACTUAL)

May 1, 2019

Study Registration Dates

First Submitted

April 16, 2020

First Submitted That Met QC Criteria

January 12, 2021

First Posted (ACTUAL)

January 14, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 8, 2021

Last Update Submitted That Met QC Criteria

March 4, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SVU-MED-84-10-12-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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