Cookies on this website
We use cookies to ensure that we give you the best experience on our website. If you click 'Continue' we'll assume that you are happy to receive all cookies and you won't see this message again. Click 'Find out more' for information on how to change your cookie settings.

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

Christine.hedges@ndm.ox.ac.uk

 00 44 (0) 1865 225893

Fax No. for both  00 44 (0) 1865 225599

Downloads

Protocol summary V9.0

Poster presentation  

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