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

January 23, 2014 updated by: University of South Florida

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • Concerta
  • methylphenidate HCl
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 Names:
  • 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:
  • placebo capsule
  • potato starch placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
29 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
29 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Florida

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Gerald Rosen, MD, Children's Hospitals and Clinics of Minnesota - St. Paul
  • Study Chair: Tom Geller, MD, St. Louis University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

May 4, 2011

First Submitted That Met QC Criteria

May 4, 2011

First Posted (Estimate)

May 5, 2011

Study Record Updates

Last Update Posted (Estimate)

February 21, 2014

Last Update Submitted That Met QC Criteria

January 23, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCUSF 0803
  • 5U10CA081920-11 (U.S. NIH Grant/Contract)
  • SCUSF-0803 (Other Identifier: SunCoast CCOP Research Base)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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