Modafinil for the treatment of fatigue in lung cancer V1.0

• Research type

  Research Study

• Full title

  Modafinil for the treatment of fatigue in lung cancer: a multi-centre, randomised, double-blinded, placebo-controlled trial

• IRAS ID

  11346

• Contact name

  Ronja Bahadori

• Sponsor organisation

  University of Oxford

• Eudract number

  2008-006486-88

• ISRCTN Number

  N/A

• Research summary

  Fatigue is a persistent, subjective sense of tiredness, which interferes with a person??s ability to function. It is believed to be both the most common and the most distressing symptom experienced by those with cancer. Despite the magnitude of the problem, there has been inadequate research into the management of cancer-related fatigue. Central nervous system stimulants are the only class of drug established as being directly effective in relieving fatigue. Traditional stimulants, such as methylphenidate (Ritilin), can cause side-effects such as difficulty sleeping at night and anxiety. Modafinil is a relatively new stimulant with few side-effects. There is increasing evidence that modafinil can reduce fatigue in healthy individuals and patients with chronic, non-cancer conditions. No good quality studies have been published evaluating modafinil in patients with cancer, despite multiple calls for such research to be undertaken. We have recently completed a small study to determine the feasibility of undertaking a larger, high quality study to assess the effect of modafinil on cancer-related fatigue. Modafinil appeared to improve fatigue rapidly, and was not associated with serious side-effects. Ten out of fifteen patients chose to continue modafinil long term. However, the study was too small for definite conclusions to be drawn. This larger, definitive study, funded by a National Cancer Research Institute research award, will establish more clearly whether modafinil can improve fatigue in patients with lung cancer. Two hundred and six patients will be recruited fromfifteensites in England and Wales. Half the patients will take modafinil and the other half will take an inactive matched placebo for 28 days. The fatigue levels of the two groups will be compared. Confirmation that modafinil can relieve cancer-related fatigue could have a highly significant impact on the quality of life of the large cohort of patients suffering from this common and debilitating symptom.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  08/H0604/171

• Date of REC Opinion

  29 Jan 2009

• REC opinion

  Further Information Favourable Opinion