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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
Mohamed Abdel Bary Ahmed Ibrahim
About
Eligibility
Locations
Arms
Outcomes
Full info

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

47 Years - 71 Years (Adult, Older Adult)All Sexes

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

    First Posted
    April 16, 2020
    Last Updated
    March 4, 2021
    Sponsor
    Mohamed Abdel Bary Ahmed Ibrahim
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    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

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    Endobronchial Cryotherapy in Management of MEBO in Patients With Inoperable NSCLC

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