Methylphenidate HCl or Modafinil in Treating Young Patients With Excessive Daytime Sleepiness After Cancer Therapy

• Status: Terminated
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of South Florida
• Collaborator: National Cancer Institute (NCI)
• Treatments: Armodafinil; Methylphenidate; Modafinil

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).