Methylphenidate in Treating Patients With Fatigue Caused by Cancer
Condition: Fatigue; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Fatigue
Intervention: methylphenidate hydrochloride; placebo
Intervention description: Given orally; Given orally
Intervention MeSH terms: Methylphenidate
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 148.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: fatigue; unspecified adult solid tumor, protocol specific

Summary:

      RATIONALE: Methylphenidate may help relieve fatigue caused by cancer. It is not yet known
      whether methylphenidate is more effective than a placebo in relieving fatigue and improving
      quality of life in patients with cancer.

      PURPOSE: This randomized phase III trial is studying methylphenidate to see how well it works
      in treating patients with fatigue caused by cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          1. ≥ 18 years of age

          2. Men or women with a history of cancer-related fatigue as defined by a score ≥ 4 on a
             fatigue numerical analogue scale (0 - 10)

          3. Fatigue for ≥ 1 month prior to registration

          4. ECOG Performance Score (PS) 0, 1, or 2

          5. Life expectancy ≥ 6 months

          6. Histologic or cytologic proven cancer other than brain cancer or CNS lymphoma

          7. Laboratory values obtained ≤ 30 days prior to registration:

               -  Hgb ≥ 10 g/dL

          8. Willing and able to provide informed consent

          9. Negative pregnancy test (urine or serum) done ≤ 7 days prior to registration, for
             women of childbearing potential only

         10. Ability to complete questionnaire(s) by themselves or with assistance

         11. Biological therapy (i.e. immunotherapy, biotherapy), chemotherapy or radiation therapy
             will be allowed

         12. Use of a stable dose of anti-depressants (except tricyclic anti-depressants) will be
             allowed

         13. Erythropoietic agents to treat anemia, and steroids as a part of cancer treatment and
             for symptom management (except for fatigue) will be allowed

        Exclusion Criteria:

          1. Hypersensitivity to methylphenidate

          2. Any prior use of methylphenidate

          3. Concomitant (≤ 2 weeks) use of prescription stimulants (pemoline, modafinil,
             amphetamines); other medications, herbal products or dietary supplements for fatigue

          4. Uncontrolled hypertension [defined as systolic blood pressure (BP) ≥ 160 mmHg and/or
             diastolic BP ≥ 100 mmHg on 2 separate visits ≤ 2 months prior to randomization]; or a
             resting heart rate > 100

          5. Moderate or severe pain as defined by an average daily score ≥ 4 on a pain analog
             scale (0 - 10)

          6. Known brain metastasis or primary CNS malignancy

          7. Clinically significant acute or chronic progressive or unstable neurologic (dementia,
             delirium, or seizure disorder), hepatic, renal, cardiovascular, thyroid, or
             respiratory disease that would limit participation in the study per MD discretion or
             judgment

          8. Psychiatric disorder such as manic depression, anxiety disorder, bipolar disorder,
             obsessive compulsive disorder, or schizophrenia

          9. Major surgery < 4 weeks prior to registration. (Note: Insertion of central venous
             catheter is not considered major surgery.)

         10. Using a drug contraindicated when taken concurrently with methylphenidate: coumarin
             anticoagulants, anticonvulsants, tricyclic antidepressants, antipsychotics, monoamine
             oxidase inhibitors, clonidine, theophylline, and pseudoephedrine

             Note: use of Compazine prescribed as an antiemetic is permitted for use while
             participating in this study.

         11. Additional medical conditions where use of methylphenidate is contraindicated:

             glaucoma, motor tics, family history or diagnosis of Tourette's syndrome, history of
             drug or alcohol abuse or intestinal obstruction.

         12. Pregnant women or nursing women. Women of childbearing potential who are unwilling to
             employ adequate contraception. This study involves an investigational agent whose
             genotoxic, mutagenic, and teratogenic effects on the developing fetus and newborn are
             unknown.

         13. Untreated hypothyroidism (TSH ≥ 5)