Long Acting Methylphenidate (Concerta™) for Cancer-Related Fatigue: A Phase III, Randomized, Double-Blind Placebo Controlled Study

Inclusion Criteria

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