Modafinil for attentional and psychomotor dysfunction in advanced cancer: a double-blind, randomised, cross-over trial.
Cognitive impairment seems to be highly prevalent in patients with advanced cancer. Modafinil, a novel vigilance and wake-promoting agent, may be an alternative treatment. We wanted to investigate this treatment on attentional and psychomotor dysfunction in cancer patients. 28 cancer patients with a tiredness score of 50 mm or more on a scale of 0 to 10 (0=no tiredness, 10=worst possible tiredness) and Karnofsky Performance Status 40-70 were included. All medications were kept stable during the trial despite short acting opioids for breakthrough pain. On day 1 the patients were randomly assigned to receive 200 mg Modafinil orally or placebo and on day 4 they crossed-over to the alternative treatment. Finger Tapping Test (FTT), Trail Making Test (TMT) and Edmonton Symptom Assessment System (ESAS) were evaluated before tablet intake and again 4, 5 hours after. FTT for the dominant hand as well as TMT were statistically significantly improved on modafinil (p-values=0.006 and 0.042, respectively). On ESAS, depression and drowsiness also improved statistically significantly (p-values=<0.001 and 0.038, respectively). Modafinil in a single dose regimen was significantly superior to placebo regarding two cognitive tests of psychomotor speed and attention. Furthermore subjective scores of depression and drowsiness were significantly improved by modafinil.
Lundorff
L E
LE
Department of Palliative Care, Herning Hospital, DK-7400 Herning, Denmark. heclun@ringamt.dk
Jønsson
B H
BH
Sjøgren
P
P
D000328:Adult; D000368:Aged; D001288:Attention / Q000187:drug effects; D001559:Benzhydryl Compounds / Q000627:therapeutic use*; D000697:Central Nervous System Stimulants / Q000627:therapeutic use*; D003072:Cognition Disorders / Q000188:drug therapy*; D018592:Cross-Over Studies; D005221:Fatigue / Q000188:drug therapy*; D005260:Female; D006801:Humans; D017567:Karnofsky Performance Status; D008297:Male; D008875:Middle Aged; D000077408:Modafinil; D009369:Neoplasms / Q000150:complications* / Q000503:physiopathology; D009483:Neuropsychological Tests; D011597:Psychomotor Performance / Q000187:drug effects*; D012890:Sleep / Q000187:drug effects
D001559:Benzhydryl Compounds; D000697:Central Nervous System Stimulants; D000077408:Modafinil