Evaluation of Stents to Open Restricted Airways in Patients With Centrally Placed Non-small Cell Lung Cancer

Summary

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.

Conditions

• Non-small Cell Lung Cancer

Interventions

OTHER

Arterial puncture

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.

OTHER

Venepuncture

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.

PROCEDURE

General anaesthetic

Patients randomised into the stenting arm will undergo rigid bronchoscopy under general anaesthetic.

PROCEDURE

Inpatient stays

Patients randomised into the stenting arm will be admitted overnight for the procedure

OTHER

Walking test

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

OTHER

Spirometry & flow volume loop assessment

All patients will undergo spirometry and flow volume loop assessments at baseline and on day 15.

OTHER

Biopsy material

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.

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust

  lead OTHER

Principal Investigators

• Mary O'Brien · Royal Marsden NHS Foundation Trust

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-09-30

Primary Completion

2010-03-31

Completion

2010-03-31

Countries

• United Kingdom

Study Locations