Modafinil for the treatment of fatigue in lung cancer
Modafinil for the treatment of fatigue in lung cancer: a multicentre, randomised, double blinded, placebo-controlled trial (Eudract no: 2008-006486-88). Funded by the Sobell House Hospice Charity and the NCRI Lung Cancer SuPaC Research Award.
Objectives
The objective of the trial is to assess the effectiveness of modafinil in the management of fatigue in non-small cell lung cancer patients. The trial also aims to evaluate the tolerability and dose-response relationship in this patient group, and to investigate the effect of Modafinil in the secondary outcomes of daytime sleepiness and depression.
Recruitment target
The trial aimed to recruit 206 participants. Recruitment was carried out via oncology clinics in centres in London, Cambridgeshire, Cheshire, Hampshire, Thames Valley, Manchester, Norfolk, Wales, Wiltshire, Kent, Yorkshire, Essex and Uxbridge.
Trial eligibility
Inclusion criteria
- Diagnosed with Non-small cell lung cancer
- Stage 3a, 3b or 4 disease, or recurrent disease after surgery or radiotherapy
- WHO performance status 0-2
- Screening score of 5 or more in a 10-point numerical rating scale of fatigue
Exclusion criteria
- Received radiotherapy or chemotherapy in the last 4 weeks
- Commenced on an EGFR tyrosine kinase inhibitor e.g. Gefitinib (Iressa®) and Erlotinib (Tarceva®) within the last 6 weeks
- Commenced on antidepressants or steroids in the last 2 weeks
- Received blood transfusion in the last 2 weeks
- Currently taking warfarin
- Potentially fertile women of childbearing age
- History of major anxiety, arrhythmia, cor pulmonale or left ventricular hypertrophy
- Uncontrolled hypertension with blood pressure of more than 160/100mmHg
Trial coordination
The trial is being coordinated through the Palliative Care trial office, The Study Centre, Sobell House, Churchill Hospital, Old Road, Headington, Oxford, OX3 7LE.
| Chief investigator | Dr Bee Wee | Bee.Wee@orh.nhs.uk |
| Administrative Support | Christine Hedges |
00 44 (0) 1865 225893 |
| Fax No. for both | 00 44 (0) 1865 225599 |
Downloads
Participating sites
| Cambridgeshire | Peterborough Hospital - Dr Kate Fife |
| Papworth Hospital - Ms Gillian Stent | |
| Cheshire | Macclesfield District Hospital - Dr Hamid Sheikh |
| Essex | Basildon and Thurrock University Hospitals - Dr Melanie Piggott |
| Hampshire | Basingstoke and North Hampshire Hospital - Dr Tony Dhillon |
| Kent | East Kent University Hospitals - Dr Declan Cawley |
| London | Royal Marsden Hospital - Dr Mary O’Brien |
| St Georges Hospital - Dr Paddy Stone | |
| Manchester | Christie Hospital - Dr Fiona Blackhall |
| Wythenshawe Hospital - Dr Yvonne Summers | |
| Norfolk | Queen Elizabeth Hospital - Dr Kathryn Waite |
| Surrey | The Royal Surrey County Hospital - Dr Andrew Davis |
| Thames Valley | Churchill Hospital - Dr Nick Bates |
| Stoke Mandeville Hospital - Dr Nick Bates | |
| Uxbridge | Hillingdon Hospital - Dr Yolanda Saunders |
| Wales | University Hospital Llandough - Dr Anthony Byrne |
| Withybush Hospital - Dr Sheikh Moeen ul Haq | |
| Wiltshire | Great Western Hospital - Dr Sarah Lowndes |
| Yorkshire | Harrogate District Hospital - Dr Samuel Chan |
| Huddersfield Royal Infirmary - Dr Barbara Cross | |
| Mid-Yorkshire Hospitals - Dr Graham Smith |
Trial team resources
A restricted area for participating sites only. Trial team resources