Non Small Cell Lung CancerNCT04710459
Endobronchial Cryotherapy in Management of MEBO in Patients With Inoperable NSCLC
A study testing cryotherapy in people with Non Small Cell Lung Cancer and Non-Small Cell Carcinoma of Lung, TNM Stage 4, run by Mohamed Abdel Bary Ahmed Ibrahim.
Trial 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… Read more about this study
- Who is it for?
- Ages 47 to 71 years
- Conditions the study is for
- Non Small Cell Lung Cancer, Non-Small Cell Carcinoma of Lung, TNM Stage 4, Bronchogenic Cancer
- What is being tested?
- cryotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 47 to 71 years
- All sexes
- Adult, Older adult
Who may be able to join
- All cases with pathologically proved and inoperable NSCLC cases based on tumor position; in the main and subsegmental bronchi.
Who cannot join
- Cases with severe respiratory distress, uncorrectable impaired bleeding profile and prechemotherapy.
About this study
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
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.
- Conditions
- Non Small Cell Lung Cancer, Non-Small Cell Carcinoma of Lung, TNM Stage 4, Bronchogenic Cancer
- Being tested
- cryotherapy
- Keywords
- Non-small cell lung cancer (NSCLC), Cryotherapy, Chemoradiotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryotherapyProcedure or surgery
Group 1 included 30 patients, they were subjected to chemoradiotherapy plus endobronchial cryotherapy. Group 2 included include 30 patients, they were subjected to chemoradiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | it included 30 patients, they were subjected to chemoradiotherapy plus endobronchial cryotherapy. Receives: Procedure: cryotherapy |
| Group 2 | No intervention | it included include 30 patients, they were subjected to chemoradiotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the clinical changes of the cases after procedure.
Evaluation of the rate of symptoms relief after therapy
Measured: 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 %).
Measured: 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
Measured: 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
Measured: The mean Karnofsky performance score was done before treatment as a baseline; and 4 weeks after treatment.
Secondary outcomes (2)
Arterial blood gases evaluation
It included; Mean So2 (mm Hg), Mean PaO2 (mmHg), Mean PaCo2 (mm Hg).
Measured: 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
Measured: Six minute walk test was done before treatment as a baseline; and 4 weeks after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study startDec 2016
- Primary completionApr 2019
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohamed Abdel Bary Ahmed Ibrahim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed Abdel Bary Ahmed Ibrahim, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04710459
- Sponsor's protocol ID
- SVU-MED-84-10-12-2016
- Status last verified
- Mar 2021
- First submitted
- 16 Apr 2020
- Last updated
- 8 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04710459
- Acronym / sponsor ID
- SVU-MED-84-10-12-2016
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mohamed Abdel Bary Ahmed IbrahimUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 14 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Procedure: cryotherapyit included 30 patients, they were subjected to chemoradiotherapy plus endobronchial cryotherapy. |
| Group 2 | No intervention | –it included include 30 patients, they were subjected to chemoradiotherapy. |
Who may qualify
- Ages
- 47 to 71 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All cases with pathologically proved and inoperable NSCLC cases based on tumor position; in the main and subsegmental bronchi.
Key exclusion criteria (1 listed)
- Cases with severe respiratory distress, uncorrectable impaired bleeding profile and prechemotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cryotherapyGroup 1 included 30 patients, they were subjected to chemoradiotherapy plus endobronchial cryotherapy. Group 2 included include 30 patients, they were subjected to chemoradiotherapy. | Procedure or surgery | Group 1 |
Primary outcome
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
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 %).
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
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
2 secondary outcomes
Arterial blood gases evaluation
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing cryotherapy in people with Non Small Cell Lung Cancer and Non-Small Cell Carcinoma of Lung, TNM Stage 4, run by Mohamed Abdel Bary Ahmed Ibrahim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2021.