Endobronchial Cryotherapy in Management of MEBO in Patients With Inoperable NSCLC
Primary Purpose
Non Small Cell Lung Cancer, Non-Small Cell Carcinoma of Lung, TNM Stage 4, Bronchogenic Cancer
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cryotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring Non-small cell lung cancer (NSCLC), Cryotherapy, Chemoradiotherapy
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Group 1
Group 2
Arm Description
it included 30 patients, they were subjected to chemoradiotherapy plus endobronchial cryotherapy.
it included include 30 patients, they were subjected to chemoradiotherapy.
Outcomes
Primary Outcome Measures
Evaluation of the clinical changes of the cases after procedure.
Evaluation of the rate of symptoms relief after therapy
Respiratory function test evaluation
Spirometry was done (FEV1 in %, FVC in %, FEV1/FVC in %).
Assessment of the overall survival
Assessment of the overall survival was done by Kaplan-Meier method
Assessment of the performance status
It was performed using the mean Karnofsky performance score
Secondary Outcome Measures
Arterial blood gases evaluation
It included; Mean So2 (mm Hg), Mean PaO2 (mmHg), Mean PaCo2 (mm Hg).
Six minute walk distance test
Six minute walk distance test was measured in minutes
Full Information
NCT ID
NCT04710459
First Posted
April 16, 2020
Last Updated
March 4, 2021
Sponsor
Mohamed Abdel Bary Ahmed Ibrahim
1. Study Identification
Unique Protocol Identification Number
NCT04710459
Brief Title
Endobronchial Cryotherapy in Management of MEBO in Patients With Inoperable NSCLC
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
April 2019 (Actual)
Study Completion Date
May 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mohamed Abdel Bary Ahmed Ibrahim
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
it included 30 patients, they were subjected to chemoradiotherapy plus endobronchial cryotherapy.
Arm Title
Group 2
Arm Type
No Intervention
Arm Description
it included include 30 patients, they were subjected to chemoradiotherapy.
Intervention Type
Procedure
Intervention Name(s)
cryotherapy
Intervention Description
Group 1 included 30 patients, they were subjected to chemoradiotherapy plus endobronchial cryotherapy. Group 2 included include 30 patients, they were subjected to chemoradiotherapy.
Primary Outcome Measure Information:
Title
Evaluation of the clinical changes of the cases after procedure.
Description
Evaluation of the rate of symptoms relief after therapy
Time Frame
the symptoms were evaluated before therapy as a baseline; and evaluated 4 weeks after procedure.
Title
Respiratory function test evaluation
Description
Spirometry was done (FEV1 in %, FVC in %, FEV1/FVC in %).
Time Frame
Change from Baseline Spirometry done before management, was compared with that was done at 4 weeks after management.
Title
Assessment of the overall survival
Description
Assessment of the overall survival was done by Kaplan-Meier method
Time Frame
The overall survival was measured by the percentage of patients who still alive for 12 months after they were started the management.
Title
Assessment of the performance status
Description
It was performed using the mean Karnofsky performance score
Time Frame
The mean Karnofsky performance score was done before treatment as a baseline; and 4 weeks after treatment.
Secondary Outcome Measure Information:
Title
Arterial blood gases evaluation
Description
It included; Mean So2 (mm Hg), Mean PaO2 (mmHg), Mean PaCo2 (mm Hg).
Time Frame
Arterial blood gases was done before treatment as a baseline; and 4 weeks after treatment.
Title
Six minute walk distance test
Description
Six minute walk distance test was measured in minutes
Time Frame
Six minute walk test was done before treatment as a baseline; and 4 weeks after treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
47 Years
Maximum Age & Unit of Time
71 Years
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Endobronchial Cryotherapy in Management of MEBO in Patients With Inoperable NSCLC
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