The positive effect of the psychostimulant modafinil on fatigue from cancer that persists after treatment is completed

G. R. Morrow, L. J. Gillies, J. T. Hickok, J. A. Roscoe, D. Padmanaban and J. J. Griggs

Univ of Rochester Cancer Ctenter, Rochester, NY

Background: Fatigue is the most common adverse effect reported by patients undergoing cancer treatment. Several large studies have shown up to 90% may experience fatigue sometime during treatment. Approximately a quarter report that their fatigue persists for months or even years beyond cancer treatment. Control of this debilitating side effect remains inadequate.

Methods: 51 Women (mean age=54.5 yrs) who completed breast cancer treatment an average of 23.5 months previously and who were reporting persistent fatigue were enrolled in a one month open label trial of modafinil (Provigil 200 mg with breakfast). Four patients did not complete the trial: 3 dropped out within a week complaining of ‘agitation’ (all were very slight with weights under 110#), 1 patient found she was unexpectedly pregnant and was withdrawn from the study. All patients completed psychometrically sound measures of fatigue and other side effects before and after treatment.

Results: The mean fatigue severity level at baseline for the 51 enrollees was 6.9 on a scale where 0 = ‘not present’ and 10 = ‘as bad as you can imagine’. After treatment, mean fatigue severity had fallen to 3.7 (p<.01). Forty-four of the 51 (86%) reported at least a one point improvement over the course of the one month study. Patient-reported global effectiveness measured after treatment supported the finding that modafinil was an effective treatment for fatigue; the mean rating was 5.0 (s.d.=2.0: with 1 = ’no benefit’ and 7 = ’great improvement’). Fifty one percent reported improvement in sleep and 51% reported less drowsiness. Additional improvements were reported by a majority of patients in general activity (64%), mood (63%), walking ability (63%), normal work ability (66%), relations with other people (66%) and enjoyment of life (61%).

Conclusions: Patients with fatigue that persisted an average of almost two years following cancer treatment experienced a benefit from modafinil in an open label trial. If these findings are confirmed by a randomized clinical trial currently underway, modafinil could provide clinical benefit for the unfortunately common side effect of cancer-related fatigue.