To determine the effectiveness of patient controlled methylphenidate as compared to placebo for the management of cancer related fatigue as determined by the Functional Assessment of Chronic Illness Therapy (FACIT)-F Fatigue score.
Primary objective: -To determine the effectiveness of patient controlled methylphenidate as compared to placebo for the management of cancer related fatigue as determined by the Functional Assessment of Chronic Illness Therapy (FACIT)-F Fatigue score Secondary objective * To assess the efficacy of as needed methylphenidate on pain, sedation and quality of life. * To assess the potential side effects of methylphenidate on appetite, insomnia and anxiety
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
112
Given PO
Given PO
M D Anderson Cancer Center
Houston, Texas, United States
To establish the effectiveness of patient the management of cancer related fatigue as determined by the Functional Assessment of Chronic Illness Therapy (FACIT)-F Fatigue score: 0-10 numerical scale.
Time frame: through study completion, an average of 1 year
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