Clinical trial NCT04710459: 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
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 60
Sex: ALL
Minimum age (years): 47
Maximum age (years): 71
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Evaluation of the clinical changes of the cases after procedure.
timeFrame: the symptoms were evaluated before therapy as a baseline; and evaluated 4 weeks after procedure.
measure: Respiratory function test evaluation
timeFrame: Change from Baseline Spirometry done before management, was compared with that was done at 4 weeks after management.
measure: Assessment of the overall survival
timeFrame: The overall survival was measured by the percentage of patients who still alive for 12 months after they were started the management.
measure: Assessment of the performance status
timeFrame: The mean Karnofsky performance score was done before treatment as a baseline; and 4 weeks after treatment.
Secondary outcomes:
measure: Arterial blood gases evaluation
timeFrame: Arterial blood gases was done before treatment as a baseline; and 4 weeks after treatment.
measure: Six minute walk distance test
timeFrame: Six minute walk test was done before treatment as a baseline; and 4 weeks after treatment.
Other outcomes:
Locations:
Study officials:
References: