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To investigate whether the use of airways stents (metal tubes to open and keep open narrowed airways) together with the standard treatment increases the proportion of patients who can complete a 6min walking distance (6MWD) test at 2 weeks +/- 2days in patients with breathlessness due to lung cancer, when compared to standard treatment alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm A | Other | Stenting of central lesion and subsequent standard palliative treatment and dyspnoea symptom control |
|
| Treatment Arm B | Other | Standard palliative treatment and standard dyspnoea symptom control. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arterial puncture | Other | Patients will undergo arterial blood gas sampling from the radial artery. This will be done by experienced doctors who are highly skilled in this procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint of the study is the proportion of patients achieving a 50% improvement in the distance walked after 2 weeks +/- 2 days of treatment as compared to their pre-treatment assessment. |
| Measure | Description | Time Frame |
|---|---|---|
| To compare arterial blood gases (oxygenation of blood) from baseline to 2 weeks +/- 2 days in the stented group, compared with the standard treatment group. | ||
| To compare lung function tests from baseline to 2 weeks +/- 2 days in the stented group, compared with the standard treatment group. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Mary O'Brien | Contact | 02086613278 | mary.o'brien@rmh.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Mary O'Brien | Royal Marsden NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Marsden NHS Foundation Trust | Recruiting | Sutton | Surrey | SM2 5PT | United Kingdom |
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| Venepuncture | Other | Blood samples for baseline biochemistry, full blood count, and clotting screen will be taken. In patients additionally providing optional consent blood will be taken for laboratory based basic science research into lung cancer carcinogenesis and pharmacogenetics. Blood will be taken by qualified and experienced nurses, doctors and phlebotomists. |
|
| General anaesthetic | Procedure | Patients randomised into the stenting arm will undergo rigid bronchoscopy under general anaesthetic. |
|
| Inpatient stays | Procedure | Patients randomised into the stenting arm will be admitted overnight for the procedure |
|
| Walking test | Other | All patients will be asked to complete a 6 minute walking test at baseline and on day 15. Patients randomised into the stent arm (Arm A) will complete a further 6 minute walking test at 24 hours post-stent |
|
| Spirometry & flow volume loop assessment | Other | All patients will undergo spirometry and flow volume loop assessments at baseline and on day 15. |
|
| Biopsy material | Other | For patients randomised to stenting and giving additional voluntary consent, 2 pairs of biopsies of tumour tissue, and 1 pair of biopsies of normal airways tissue will be taken for basic scientific research into lung cancer carcinogenesis, and pharmacogenetics. |
|
| To compare other symptoms such as anxiety and breathlessness, as measured by standard scales (e.g. VAS, Borg scales) from baseline to 2 weeks +/- 2 days in the stented group, compared with the standard treatment group |
| To measure quality of life with standard questionnaires |
| To compare survival rates at 6 months and 1 year between the stented group and standard treatment group |
| To document any subsequent treatments given to patients in each group |
| To establish the feasibility of collecting fresh and formalin fixed, paraffin embedded tumour and normal bronchial tissue, and germ-line DNA for future research into NSCLC carcinogenesis and corollary translational work |
| Formal objective response assessment is not required at 3 months, but where this is possible, this will be described |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D000402 | Airway Obstruction |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D000768 | Anesthesia, General |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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