Randomisierte, prospektive Doppelblindstudie über die Auswirkung von Ritalin und Vigil im Vergleich zu einem Placebo auf Fatigue und Lebensqualität bei Tumorpatienten, die stark wirksame Opioide gegen ihre Schmerzen erhalten

Advanced cancer, anticancer treatment and opiods against pain can cause fatigue. The fatigue-syndrome implies cognitive/mental aspects and/or physical tiredness (asthenia) and negatively impacts on quality of life. The goal of this study was to find out if modafinil or methylphendidate can improve the fatigue-syndrome in a coherent and defined group with advanced and incurable cancer. In a randomized, prospective, double blind study, 31 patients were treated with methylphenidate (group = G1, 5 mg to breakfast, 5 mg to lunch), modafinil (group = G2, 100 mg to breakfast, 100 mg to lunch) or placebo (group = G3 ,one pill to breakfast and lunch) for up to 28 days. These patients were separated randomly and double blindly into three groups. Fatigue and quality of life were measured four times using the MFI-20 questionnaire and QLQ-C30 (day 0, 7,14 ,28). Clinical and lab tests (hemoglobin, ALAT, ASAT,creatinine) were also performed. Quality of life decreased over 28 days in G3 (-38.87%), but increased in G2 (+16.63%) and G1 (+22.89%). Physical functioning increased more in G2 (+ 12,28%) and in G1 (+5,29%) than in G3 (+1,61%). MFI-20 presents variable results. General fatigue could be hold steady from day 0 to day 28 in G1(+0,60%), while placebo (+5,87) and Modafinil (+ 17,09%) showed enhancement. Physical fatigue declined from day 0 to day 7 in G1 (-11,88%), as well as with placebo (-3,79%) and remained steady with Modafinil (+1,57%). Surprisingly placebo was able to keep mental fatigue from day 0 to 28 constant (-0,09%), where as G2 (+9,87%) and G1 (+37,45%) increased it. Reduced activity increased in all three groups over 28 days, but less in G1 (+2,78%) than in G2(+10,93%) or G3 (+16,76%). Reduced motivation was lowered from day 0 to day 7 in G2 and G1 (-14,88%, -1,06%), in G3 it elevated (+28,13%). Modafinil and Methylphenidate improve quality of life and fatigue, but mental fatigue remains constant.