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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Group 1 included 30 patients, they were subjected to chemoradiotherapy plus endobronchial cryotherapy. Group 2 included include 30 patients, they were subjected to chemoradiotherapy.
Evaluation of the clinical changes of the cases after procedure.
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.
Respiratory function test evaluation
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.
Assessment of the overall survival
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.
Assessment of the performance status
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.
Arterial blood gases evaluation
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.
Six minute walk distance test
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.
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