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

This study has been terminated.
(Study only randomized 1 subject and was determined not feasible by DSMB)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT01348607
First received: May 4, 2011
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Central Nervous System Tumor, Pediatric
Fatigue
Specific Disorders of Sleep
Drug: methylphenidate hydrochloride
Drug: modafinil
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • Average Daytime Napping Minutes in a Week [ Time Frame: 29 days ] [ Designated as safety issue: No ]
    Outcome measure was the total of daytime napping minutes in a week as assessed by participant sleep diaries


Secondary Outcome Measures:
  • Adverse Events [ Time Frame: 29 days ] [ Designated as safety issue: Yes ]
    Adverse events assessed at all subject visits by interviews with the subject and the subject's parent/ primary caregiver.


Enrollment: 1
Study Start Date: July 2010
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Given orally
Other Names:
  • methylphenidate HCl
  • Concerta
Experimental: Arm II -modafinil
Patients receive oral modafinil once daily for 7-42 days in the absence of unacceptable toxicity.
Drug: modafinil
Given orally
Other Name: Provigil
Placebo Comparator: Arm III placebo
Patients receive oral placebo once daily for 7-42 days in the absence of unacceptable toxicity.
Drug: placebo
Given orally
Other Names:
  • potato starch placebo
  • placebo capsule

Detailed 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.

  Eligibility

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01348607

Sponsors and Collaborators
University of South Florida
Investigators
Study Chair: Gerald Rosen, MD Children's Hospitals and Clinics of Minnesota - St. Paul
Study Chair: Tom Geller, MD St. Louis University
  More Information

No publications provided

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT01348607     History of Changes
Other Study ID Numbers: SCUSF 0803, SCUSF-0803, 5U10CA081920-11
Study First Received: May 4, 2011
Results First Received: July 5, 2013
Last Updated: January 23, 2014
Health Authority: United States: Data and Safety Monitoring Board
United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of South Florida:
psychosocial effects of cancer and its treatment
sleep disorders
fatigue
childhood craniopharyngioma

Additional relevant MeSH terms:
Fatigue
Nervous System Neoplasms
Central Nervous System Neoplasms
Signs and Symptoms
Neoplasms by Site
Neoplasms
Nervous System Diseases
Methylphenidate
Modafinil
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on April 21, 2014