Methylphenidate HCl or Modafinil in Treating Young Patients With Excessive Daytime Sleepiness After Cancer Therapy
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.
|Central Nervous System Tumor, Pediatric Fatigue Specific Disorders of Sleep||Drug: methylphenidate hydrochloride Drug: modafinil Drug: placebo||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
|Official Title:||A Randomized, Phase II Placebo-controlled Study of the Use of Extended-release Methylphenidate or Modafinil for the Treatment of Excessive Daytime Sleepiness in Children Following Cancer Therapy|
- Average Daytime Napping Minutes in a Week [ Time Frame: 29 days ]Outcome measure was the total of daytime napping minutes in a week as assessed by participant sleep diaries
- Adverse Events [ Time Frame: 29 days ]Adverse events assessed at all subject visits by interviews with the subject and the subject's parent/ primary caregiver.
|Study Start Date:||July 2010|
|Study Completion Date:||December 2012|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Experimental: Arm I - methylphenidate hydrochloride
Patients receive oral methylphenidate extended-release once daily for 7-42 days in the absence of unacceptable toxicity.
Drug: methylphenidate hydrochloride
Experimental: Arm II -modafinil
Patients receive oral modafinil once daily for 7-42 days in the absence of unacceptable toxicity.
Other Name: Provigil
Placebo Comparator: Arm III placebo
Patients receive oral placebo once daily for 7-42 days in the absence of unacceptable toxicity.
- Compare the efficacy of methylphenidate hydrochloride and modafinil to placebo in pediatric patients with excessive daytime sleepiness following cancer therapy.
- Compare the efficacy of half dose methylphenidate hydrochloride and modafinil to placebo in these patients.
- Assess the effects of these regimens on daytime sleepiness as measured by the Pediatric Daytime Sleepiness Scale or the Cleveland Adolescent Sleepiness Questionnaire.
- Assess the effects of somnolence symptoms on fatigue as measured by the PedsQL Multidimensional Fatigue Scale.
- Assess the effects of somnolence symptoms on the quality of life as measured by the PedsQL Quality of Life Inventory 4.0.
- Determine the incidence of side effects associated with these regimens.
- Determine the prevalence of sleep complaints as measured by the Pediatric Sleep Questionnaire. (Exploratory)
OUTLINE: This is a multicenter study. Patients are stratified according to age (8-10 years vs 11-12 years vs 13-17 years vs 18-25 years). Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive oral methylphenidate hydrochloride extended-release once daily for 7-42 days in the absence of unacceptable toxicity.
- Arm II: Patients receive oral modafinil once daily for 7-42 days in the absence of unacceptable toxicity.
- Arm III: Patients receive oral placebo once daily for 7-42 days in the absence of unacceptable toxicity.
Patients or their parents complete age-specific sleep and quality-of-life questionnaires at baseline and after completion of treatment. Patients or their parents complete daily sleep diaries during the study to collect information about the date, type of day (school, weekend, or vacation), hours of sleep, anytime the actigraph was removed during the day, time the child went to bed, and time the child got out of bed in the morning. Patients are also instructed to wear an actigraph on their non-dominant wrist for 1 week before starting treatment and during the first and last week of treatment (3 weeks total) to assess sleep-wake patterns.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01348607
|Study Chair:||Gerald Rosen, MD||Children's Hospitals and Clinics of Minnesota - St. Paul|
|Study Chair:||Tom Geller, MD||St. Louis University|