Modafinil for the Treatment of Fatigue in Lung Cancer V9.0
Status:
Completed
Trial end date:
2012-05-01
Target enrollment:
Participant gender:
Summary
Fatigue is a persistent, subjective sense of tiredness, which interferes with a person's
usual 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 (CNS) stimulants are the only class of drug established as being
directly effective in relieving fatigue. Traditional stimulants, such as methylphenidate
(Ritalin), 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.
The investigators have completed a small study to determine the feasibility of undertaking a
larger, high quality study to assess the effect of modafinil on fatigue in patients with lung
cancer. Modafinil appeared to improve fatigue rapidly and was not associated with serious
side-effects. Ten of the fifteen patients who completed the study 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 from a number of sites across the UK.
Half of the patients will take modafinil, and the other half will take a 'dummy' tablet every
day for a month. 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 very large number of patients suffering from this common and
distressing symptom.