Methylphenidate in Treating Patients With Fatigue Caused by Cancer

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed cancer, except for any of the following:

  • Brain cancer, including primary CNS malignancy or brain metastases
  • CNS lymphoma

• History of cancer-related fatigue, as defined by a score of ≥ 4 on a fatigue numerical analogue scale (0-10)

  • Has had fatigue for ≥ 1 month
• No moderate or severe pain, as defined by an average daily score ≥ 4 on a pain analog scale (0-10)

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2
• Life expectancy ≥ 6 months
• Hemoglobin ≥ 10 g/dL
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No hypersensitivity to methylphenidate
• No uncontrolled hypertension, defined as systolic blood pressure (BP) ≥ 160 mm Hg and/or diastolic BP ≥ 100 mm Hg on 2 separate visits ≤ 2 months apart
• No resting heart rate > 100
• No clinically significant acute or chronic progressive or unstable neurologic (dementia, delirium, or seizure disorder), hepatic, renal, cardiovascular, thyroid, or respiratory disease that would preclude study participation

• No psychiatric disorder, including any of the following:

  • Manic depression
  • Anxiety disorder
  • Bipolar disorder
  • Obsessive compulsive disorder
  • Schizophrenia

• None of the following medical conditions for which the use of methylphenidate is contraindicated:

  • Glaucoma
  • Motor tics
  • Family history or diagnosis of Tourette's syndrome
  • History of drug or alcohol abuse
  • Intestinal obstruction
• No untreated hypothyroidism (i.e., thyroid-stimulating hormone ≥ 5)

PRIOR CONCURRENT THERAPY:

• No prior methylphenidate

• More than 4 weeks since prior major surgery

  • Insertion of a central venous catheter is not considered major surgery
• More than 2 weeks since prior and no concurrent prescription stimulants (e.g., pemoline, modafinil, or amphetamines) or other medications, herbal products, or dietary supplements for fatigue

• No concurrent administration of any of the following:

  • Coumarin anticoagulants
  • Anticonvulsants

  • Tricyclic antidepressants

    • A stable dose of other antidepressants allowed
  • Antipsychotics
  • Monoamine oxidase inhibitors
  • Clonidine
  • Theophylline
  • Pseudoephedrine
  • Compazine prescribed as an antiemetic allowed
• Concurrent biological therapy, chemotherapy, or radiotherapy allowed
• Concurrent erythropoietic agents to treat anemia allowed
• Concurrent steroids as a part of cancer treatment and for symptom management (except for fatigue) allowed