Impact of smoking cessation on multi-drug resistance in patients undergoing chemotherapy for non small cell lung cancer (NSCLC)

ISRCTN	ISRCTN48355604
DOI	https://doi.org/10.1186/ISRCTN48355604
Secondary identifying numbers	N0051160968

Submission date: 29/09/2006
Registration date: 29/09/2006
Last edited: 17/10/2012

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Ken Miles
Scientific

Brighton & Sussex University Hospitals NHS Trust (RSCH)
Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
United Kingdom

Phone	+44
Email	kenneth.miles@ucl.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study objectives	The purpose of this study is to determine whether patients with non-small cell lung cancer should be advised to stop smoking during chemotherapy. The hypothesis is that cessation of smoking will reduce the resistance of these patients tumours to therapy. The study aims to use a nuclear medicine test known as Tc-99m MIBI imaging to compare changes in drug resistance in smokers undergoing chemotherapy for non-small cell lung cancer randomised to cessation or continuation of smoking. A reduction in PGP expression on cessation of smoking would suggest that patients would benefit from stopping smoking during chemotherapy.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cancer: Non small cell lung cancer
Intervention	Patients: a pilot study will be performed comprising 18 smokers (at least 20/day) with non-small cell lung cancer who are to undergo chemotherapy. The study will provide preliminary data that will form the basis of an application for funding for subsequent larger trial. Study Design: All patients will undergo biphasic Tc-99m MIBI imaging before chemotherapy. Patients will then be randomised to cessation or continuation of smoking. Tc-99m MIBI imaging will be repeated one week after the completion of the first cycle of chemotherapy. Imaging: For each imaging study, patients will receive 600 MBq Tc-99m MIBI intravenously with 5 minute images acquired on a double- headed gamma camera at 15 minutes and 180 minutes. A region of interest will be drawn over the tumour on anterior and posterior images and geometric mean values of tumour activity will be determined. The MIBI wash-out will be determined from the ratio of tumour counts on early and late images. Initial (15 min) and residual (180 min) tumour uptake of MIBI will also be expressed as a target-to-background (TB) ratios by comparison with a mirror-image ROI placed over the opposite lung. Statistical analysis: The mean changes in initial and residual tumour uptake and tumour MIBI washout rate before and after chemotherapy will be compared between patients who stopped smoking and those who continues using non-parametric tests. If the differences are not statistically significant, the data will be used for power analysis to determine the sample-size required for future studies. As of March 2008: trial abandoned due to an inability to recruit patients who would continue smoking.
Intervention type	Other
Primary outcome measure	The study aims to use serial imaging with Tc-99m MIBI to compare changes in expression of PGP mediated multi-drug resistance in smokers undergoing chemotherapy for non-small cell lung cancer randomised to cessation or continuation of smoking. A reduction in PGP expression on cessation of smoking would suggest that patients would benefit from stopping smoking during chemotherapy.
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/08/2005
Completion date	31/07/2006
Reason abandoned (if study stopped)	Participant recruitment issue

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	18
Key inclusion criteria	1. 18 smokers (at least 20/day) with NSCLC will be included in the study. 2. Patients will be identified, approached and recruited by Dr Mitra (consultant oncologist) in the oncology clinic.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/08/2005
Date of final enrolment	31/07/2006

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Brighton & Sussex University Hospitals NHS Trust (RSCH)

Brighton
BN2 5BE
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Brighton and Sussex University Hospitals NHS Trust (UK)

No information available

NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan