Methylphenidate HCl or Modafinil in Treating Young Patients With Excessive Daytime Sleepiness After Cancer Therapy
Condition: Central Nervous System Tumor, Pediatric; Fatigue; Specific Disorders of Sleep
MeSH terms: Nervous System Neoplasms; Central Nervous System Neoplasms; Disorders of Excessive Somnolence; Fatigue; Sleepiness
Intervention: methylphenidate hydrochloride; modafinil; placebo
Intervention description: Given orally; Given orally; Given orally
Intervention MeSH terms: Methylphenidate; Modafinil
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1.0
Sex: All
Minimum age: 8 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: psychosocial effects of cancer and its treatment; sleep disorders; fatigue; childhood craniopharyngioma

Summary:

      RATIONALE: Methylphenidate hydrochloride or modafinil may help reduce daytime sleepiness and
      improve the quality of life of patients with excessive daytime sleepiness after cancer
      therapy. It is not yet known whether methylphenidate hydrochloride or modafinil are more
      effective than a placebo in reducing daytime sleepiness in these patients.

      PURPOSE: This randomized phase II trial is studying methylphenidate hydrochloride or
      modafinil to see how well they work compared with a placebo in treating young patients with
      excessive daytime sleepiness after cancer therapy.
    

Eligibility criteria:

        INCLUSION CRITERIA:

          -  Patient and family must agree to return to the clinic up to 8 times within 2 months

          -  Children ≥ 8 and <18 years of age at the time of study entry who were previously
             treated for:

          -  a hypothalamic tumor

          -  mid-line brain tumor

          -  a tumor involving one or both thalami

          -  craniopharyngioma

          -  diagnosis of hydrocephalus secondary to a brain tumor or treatment of a brain tumor
             that required placement of a permanent shunt.

          -  Off cancer treatment for at least six months

          -  Proficient in English

          -  Able to swallow capsules

          -  Experiencing symptoms of excessive daytime sleepiness (EDS) for at least three months
             prior to study entry that is not a result of inadequate sleep hygiene or other known
             medical disorder.

          -  Negative pregnancy test

        EXCLUSION CRITERIA:

          -  Patients treated with doxorubicin or high dose cyclophosphamide

          -  History of a clinically significant drug sensitivity to methylphenidate, modafinil,
             armodafinil or any of their components

          -  Known cardiac disorders including arrhythmias, hypertension requiring treatment or
             structural heart disease

          -  Have taken methylphenidate or modafinil within the last 14 days

          -  Current/concurrent use of antihistamines, benzodiazepine, anticonvulsants or alcohol

          -  Clinical diagnosis of major depression, subclinical depression, or anxiety disorder

          -  History of psychosis or mania

          -  Patients with suicidal ideation

          -  Diagnosis with anemia, untreated hypothyroidism, mononucleosis or narcolepsy

          -  History of substance abuse

          -  Pregnant or breast feeding

          -  A total dietary intake of more than 500 mg of caffeine per day (e.g., approximately
             ten 330 mL cans of soft drinks, five cups of coffee or tea, or 750 g chocolate per
             day).