Methylphenidate Hydrochloride or Modafinil in Treating Young Patients With Excessive Daytime Sleepiness After Cancer Therapy
Status: Recruiting
Phase:
Diagnosis: Pediatric Brain Tumor
NCT ID: NCT01348607
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-190
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.
Conducting Institutions:
Dana-Farber Cancer Institute, Children's Hospital Boston
Overall PI:
Peter Manley, MD,
Dana-Farber Cancer Institute
Site-responsible Investigators:
Contacts:
Dana-Farber Cancer Institute:
Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP,
ctip@partners.org
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Previously treated for one of the following:
- Hypothalamic tumor
- Mid-line brain tumor
- Tumor involving one or both thalami
- Craniopharyngioma
- Hydrocephalus secondary to a brain tumor or brain tumor that required placement
of a permanent shunt
- Completed cancer treatment ≥ 6 months ago
- Has excessive daytime sleepiness (EDS), as defined by a score of > 0.33 on the
Extended Daytime Sleepiness subscale of the Pediatric Sleepiness Questionnaire (PSQ)
AND a score of ≤ 0.33 on the Sleep-Related Breathing Disorders subscale of the PSQ
- Has had symptoms of EDS for ≥ 3 months that are not a result of inadequate sleep
hygiene or other medical disorder, as measured by either of the following:
- Score ≥ 20 on the Pediatric Daytime Sleepiness Scale (for patients 8-10
years of age)
- Score ≥ 43 on the Cleveland Adolescent Sleepiness Questionnaire (for
patients 11-17 years of age)
- No diagnosis of attention-deficit hyperactivity disorder or EDS prior to receiving
cancer treatment
PATIENT CHARACTERISTICS:
- Proficient in English
- Able to swallow capsules
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception
- No history of a clinically significant drug sensitivity to methylphenidate,
modafinil, armodafinil, or any of their components
- No know cardiac disorders, including any of the following:
- Arrhythmias
- Hypertension requiring treatment
- Structural heart disease
- No clinical diagnosis of major depression, subclinical depression, or anxiety
disorder
- No history of psychosis or mania
- No suicidal ideation
- No history of substance abuse
- No anemia, untreated hypothyroidism, mononucleosis, or narcolepsy
- No total dietary intake of > 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 of chocolate per day)
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior doxorubicin hydrochloride or high-dose cyclophosphamide
- More than 90 days since prior methylphenidate or modafinil
- No concurrent antihistamines, benzodiazepines, anticonvulsants, or alcohol
- No concurrent oral birth control for contraception