Methylphenidate for Fatigue in Advanced Cancer Patients

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DESCRIPTION (provided by applicant): Fatigue is one of the most common and devastating symptoms in patients with advanced cancer. Alleviating fatigue has the potential to greatly improve the quality of life of patients with advanced cancer. Different mechanisms, directly or interactively, impact on brain function to cause the subjective symptom of fatigue. Previous research by our group and others suggests that methylphenidate, a mild central nervous system stimulant, is capable of improving the subjective perception of fatigue. In the process of conducting fatigue and other symptom management studies, we determined that patients found a daily phone call by a research nurse extremely beneficial, leading us to hypothesize that nursing phone calls might provide a therapeutic effect on fatigue and psychosocial symptoms by reducing uncertainty associated with chronic illness. Specifically, we hypothesize that fatigue and fatigue-related symptoms will improve in patients receiving methylphenidate as compared to a placebo and that patients receiving nursing telephone follow-up care will experience lower symptom intensity and higher quality of life as compared to those receiving standard care. We also hypothesize that there is a synergistic effect of methylphenidate plus nursing phone calls on the reduction of fatigue as compared to the effects of either methylphenidate or nursing phone calls alone on cancer-related fatigue. To test these hypotheses, we propose a randomized, placebo-controlled 2-week study in 212 patients with metastatic or incurable cancer comparing methylphenidate versus placebo; half of the patients in the drug arm and half in the placebo arm will be randomized to receive nursing follow-up phone calls every 2 days while the other half of the randomized sample will receive standard care.