Contact information
Type
Scientific
Primary contact
Prof Ken Miles
ORCID ID
Contact details
Brighton & Sussex University Hospitals NHS Trust (RSCH)
Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
United Kingdom
+44
kenneth.miles@ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0051160968
Study information
Scientific title
Acronym
Study hypothesis
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 patientsÂ’ 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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/08/2005
Overall trial end date
31/07/2006
Reason abandoned (if study stopped)
Participant recruitment issue
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
18
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/08/2005
Recruitment end date
31/07/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Brighton & Sussex University Hospitals NHS Trust (RSCH)
Brighton
BN2 5BE
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Brighton and Sussex University Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list