Modafinil for the Treatment of Fatigue in Lung Cancer V1.0
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 just 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 eight sites in England. 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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Modafinil for the Treatment of Fatigue in Lung Cancer: a Multicentre, Randomised, Double-blinded, Placebo-controlled Trial|
- The fatigue subscale of the Functional Assessment of Chronic Illness Therapy measurement system [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- Epworth Sleepiness Scale [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- Hospital Anxiety and Depression Scale [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- Quality of life linear analogue scale [ Time Frame: 28 days ] [ Designated as safety issue: No ]
|Study Start Date:||February 2009|
|Estimated Study Completion Date:||September 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
|Experimental: Treatment group||
Modafinil 100mg once daily for 14 days, increasing to 200mg once daily for a further 14 days
|Placebo Comparator: Control group||
One capsule daily for 14 days, increasing to two capsules daily for 14 days
|Stoke Mandeville Hospital|
|Aylesbury, United Kingdom, HP21 8AL|
|St George's Hospital|
|London, United Kingdom, SW17 0RE|
|Royal Marsden Hospital|
|London, United Kingdom, SM25PT|
|Manchester, United Kingdom, M23 9LT|
|Manchester, United Kingdom, M20 4BX|
|Oxford, United Kingdom, OX3 7LJ|
|Papworth Everard, United Kingdom, CB23 3RE|
|Peterborough District Hospital|
|Peterborough, United Kingdom, PE3 6DA|