TY - JOUR
T1 - A randomized, double-blind, 2-period, placebo-controlled crossover trial of a sustained-release methylphenidate in the treatment of fatigue in cancer patients
AU - Escalante, Carmen P.
AU - Meyers, Christina
AU - Reuben, James M.
AU - Wang, Xuemei
AU - Qiao, Wei
AU - Manzullo, Ellen
AU - Alvarez, Ricardo H.
AU - Morrow, Phuong Khanh
AU - Gonzalez-Angulo, Ana M.
AU - Wang, Xin Shelley
AU - Mendoza, Tito
AU - Liu, Wenli
AU - Holmes, Holly
AU - Hwang, Jessica
AU - Pisters, Katherine
AU - Overman, Michael
AU - Cleeland, Charles
PY - 2014/1
Y1 - 2014/1
N2 - PURPOSE: This study assessed the efficacy of methylphenidate versus placebo for cancer-related fatigue reduction. Other objectives were to analyze cytokine levels and to determine the effects of methylphenidate on other symptoms, cognitive function, work yield, and patients' perceptions and preferences. METHODS: Patients were randomly assigned (1:1) to receive methylphenidate- placebo or placebo-methylphenidate for 4 weeks. Patients crossed over after 2 weeks. Wilcoxon signed rank tests and McNemar tests were used to assess continuous and categorical variables. The primary efficacy endpoint was change in the level of worst fatigue on the Brief Fatigue Inventory (BFI) at the end of each 2-week period. RESULTS: The mean baseline BFI score was moderate (5.7). Methylphenidate treatment did not affect patients' worst level of fatigue or other symptoms. Results from the Wechsler Adult Intelligence Scale Digit Symbol Test and the Hopkins Verbal Learning Test with BFI interference questions and BFI activity questions showed significant improvement in the methylphenidate-treated patients' verbal learning, memory, visual perception, analysis, and scanning speed. Patients treated with methylphenidate missed significantly fewer work hours owing to health reasons and worked significantly more hours. After 4 weeks, 64% of patients reported that methylphenidate improved their cancer-related fatigue, and 58% wanted to continue treatment. Significant difference in interleukin 6R (positive), interleukin 10 (negative), and tumor necrosis factor α (positive) was noted between the methylphenidate and the placebo group. CONCLUSIONS: Low-dose methylphenidate did not improve cancer-related fatigue. Patients taking methylphenidate had better cognition and were able to work more hours. Patients tolerated methylphenidate well, and the majority felt better and wanted to continue treatment.
AB - PURPOSE: This study assessed the efficacy of methylphenidate versus placebo for cancer-related fatigue reduction. Other objectives were to analyze cytokine levels and to determine the effects of methylphenidate on other symptoms, cognitive function, work yield, and patients' perceptions and preferences. METHODS: Patients were randomly assigned (1:1) to receive methylphenidate- placebo or placebo-methylphenidate for 4 weeks. Patients crossed over after 2 weeks. Wilcoxon signed rank tests and McNemar tests were used to assess continuous and categorical variables. The primary efficacy endpoint was change in the level of worst fatigue on the Brief Fatigue Inventory (BFI) at the end of each 2-week period. RESULTS: The mean baseline BFI score was moderate (5.7). Methylphenidate treatment did not affect patients' worst level of fatigue or other symptoms. Results from the Wechsler Adult Intelligence Scale Digit Symbol Test and the Hopkins Verbal Learning Test with BFI interference questions and BFI activity questions showed significant improvement in the methylphenidate-treated patients' verbal learning, memory, visual perception, analysis, and scanning speed. Patients treated with methylphenidate missed significantly fewer work hours owing to health reasons and worked significantly more hours. After 4 weeks, 64% of patients reported that methylphenidate improved their cancer-related fatigue, and 58% wanted to continue treatment. Significant difference in interleukin 6R (positive), interleukin 10 (negative), and tumor necrosis factor α (positive) was noted between the methylphenidate and the placebo group. CONCLUSIONS: Low-dose methylphenidate did not improve cancer-related fatigue. Patients taking methylphenidate had better cognition and were able to work more hours. Patients tolerated methylphenidate well, and the majority felt better and wanted to continue treatment.
KW - Cancer-related fatigue
KW - cancer
KW - methylphenidate
KW - stimulant
KW - sustained-release methylphenidate
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U2 - 10.1097/PPO.0000000000000018
DO - 10.1097/PPO.0000000000000018
M3 - Article
C2 - 24445757
AN - SCOPUS:84893543233
SN - 1528-9117
VL - 20
SP - 8
EP - 14
JO - Cancer Journal (United States)
JF - Cancer Journal (United States)
IS - 1
ER -