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 |
| Protocol serial number | N0051160968 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Funders | Brighton and Sussex University Hospitals NHS Trust (UK), NHS R&D Support Funding |
- 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
Scientific
Brighton & Sussex University Hospitals NHS Trust (RSCH)
Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
United Kingdom
| Phone | +44 |
|---|---|
| kenneth.miles@ucl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 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(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(s) |
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. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| 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 sample size at registration | 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
- United Kingdom
- England
Study participating centre
Brighton & Sussex University Hospitals NHS Trust (RSCH)
Brighton
BN2 5BE
United Kingdom
BN2 5BE
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
