Condition category
Cancer
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
17/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes