Patient Controlled Methylphenidate for Cancer Related Fatigue: A Double Blind, Randomized, Placebo Controlled Trial

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

Inclusion criteria

• Presence of fatigue on a numerical scale during the last 24 hours of more or equal to 4 on a 0 to 10 scale in which 0 equals no fatigue and 10 worst possible fatigue.
• Patients should describe fatigue as being present for a minimum of four days.
• If patients are on opioids for the treatment of cancer pain, change of opioids is allowed.
• No clinical evidence of cognitive failure, with normal Mini Mental State Examination (MMSE). A score of 24 is considered as normal.
• Sign written informed consent.
• Patients must be 18 years or older.
• Patient willing to keep a daily diary, engage in daily telephone follow up with a nurse, and after 7 days of treatment patient will return for a follow up visit.
• Patient must have telephone access to be contacted daily by the research nurse.
• Hemoglobin of >/=10 g/dl within 2 weeks of enrollment. If the patient has not had blood drawn for a hemoglobin level in the past two weeks, one will be done to determine the eligibility.

Exclusion criteria

• Major contraindication to methylphenidate i.e. hypersensitivity, anxiety, tension, agitation, or motor tics
• Currently on methylphenidate or has been on methylphenidate within the last 10 days.
• Inability to complete the baseline assessment forms or to understand the recommendations for participation in the study.
• Pregnant or lactating women.
• Patients taking MAO inhibitors, tricyclic antidepressants and clonidine.
• Patients with glaucoma, history of marked anxiety disorder, or history of substance abuse.
• CAGE questionnaire score for the last 2 years is 2 or above on a 0 to 4 scale
• History of Tourette's syndrome
• Patients with tachycardia and uncontrolled hypertension.