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Methylphenidate and/or a nursing telephone intervention for fatigue in patients with advanced cancer : a randomized , placebo-controlled , phase II trial . PURPOSE Cancer-related-fatigue ( CRF ) is common in advanced cancer . The primary objective of the study was to compare the effects of methylphenidate ( MP ) with those of placebo ( PL ) on CRF as measured using the Functional Assessment of Chronic Illness Therapy-Fatigue ( FACIT-F ) fatigue subscale . The effect of a combined intervention including MP plus a nursing telephone intervention ( NTI ) was also assessed . PATIENTS AND METHODS Patients with advanced cancer with a fatigue score of ≥ 4 out of 10 on the Edmonton Symptom Assessment Scale ( ESAS ) were randomly assigned to one of the following four groups : MP+NTI , PL+NTI , MP + control telephone intervention ( CTI ) , and PL+CTI . Methylphenidate dose was 5 mg every 2 hours as needed up to 20 mg per day . The primary end point was the median difference in FACIT-F fatigue at day 15 . Secondary outcomes included anxiety , depression , and sleep . RESULTS One hundred forty-one patients were evaluable . Median FACIT-F fatigue scores improved from baseline to day 15 in all groups : MP+NTI ( median score , 4.5 ; P = .005 ) , PL+NTI ( median score , 8.0 ; P < .001 ) , MP+CTI ( median score , 7.0 ; P = .004 ) , and PL+CTI ( median score , 5.0 ; P = .03 ) . However , there were no significant differences in the median improvement in FACIT-F fatigue between the MP and PL groups ( 5.5 v 6.0 , respectively ; P = .69 ) and among all four groups ( P = .16 ) . Fatigue ( P < .001 ) , nausea ( P = .01 ) , depression ( P = .02 ) , anxiety ( P = .01 ) , drowsiness ( P < .001 ) , appetite ( P = .009 ) , sleep ( P < .001 ) , and feeling of well-being ( P < .001 ) , as measured by the ESAS , significantly improved in patients who received NTI . Grade ≥ 3 adverse events did not differ between MP and PL ( 40 of 93 patients v 29 of 97 patients , respectively ; P = .06 ) . CONCLUSION MP and NTI alone or combined were not superior to placebo in improving CRF .
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Intervention_Pharmacological
Methylphenidate
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Intervention_Educational
nursing telephone intervention
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
methylphenidate ( MP )
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Intervention_Control
placebo
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Intervention_Educational
nursing telephone intervention ( NTI )
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Outcome_Physical
fatigue
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Outcome_Physical
Cancer-related-fatigue ( CRF )
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Outcome_Physical
Functional Assessment of Chronic Illness Therapy-Fatigue ( FACIT-F )
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Participant_Condition
patients with advanced cancer :
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Participant_Condition
advanced cancer .