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

Fatigue Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01348607
• Other study ID #: SCUSF 0803
• Secondary ID: SCUSF-08035U10CA
• Status: Terminated
• Phase: Phase 2
• First received: May 4, 2011
• Last updated: January 23, 2014
• Start date: July 2010
• Est. completion date: December 2012

Study information

• Verified date: January 2014
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring BoardUnited States: Federal GovernmentUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

OBJECTIVES:

Primary

• Compare the efficacy of methylphenidate hydrochloride and modafinil to placebo in pediatric patients with excessive daytime sleepiness following cancer therapy.

Secondary

• 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 18 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Central Nervous System Neoplasms
• Central Nervous System Tumor, Pediatric
• Fatigue
• Nervous System Neoplasms
• Specific Disorders of Sleep

Intervention

Drug:
• methylphenidate hydrochloride
Given orally
• modafinil
Given orally
• placebo
Given orally

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of South Florida	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Daytime Napping Minutes in a Week	Outcome measure was the total of daytime napping minutes in a week as assessed by participant sleep diaries	29 days	No
Secondary	Adverse Events	Adverse events assessed at all subject visits by interviews with the subject and the subject's parent/ primary caregiver.	29 days	Yes