Methylphenidate HCl or Modafinil in Treating Young Patients With Excessive Daytime Sleepiness After Cancer Therapy
This study has been terminated.
(Study only enrolled 4 subjects and was determined not feasible by DSMB)
Sponsor:
University of South Florida
Collaborator:
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT01348607
First received: May 4, 2011
Last updated: May 20, 2013
Last verified: January 2012
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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 |
|---|---|---|
|
Brain and Central Nervous System Tumors Fatigue Psychosocial Effects of Cancer and Its Treatment Sleep Disorders |
Drug: methylphenidate hydrochloride Drug: modafinil Other: 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 as measured by actigraphy [ Time Frame: 29 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Improvement in symptoms associated with excessive daytime sleepiness as measured by the Cleveland Adolescent Sleepiness Questionnaire or Pediatric Daytime Sleepiness Scale [ Time Frame: 29 days ] [ Designated as safety issue: No ]
- Change in the average daily napping minutes from baseline to days 8-14 [ Time Frame: 29 days ] [ Designated as safety issue: No ]
- Quality of life as measured by the PedsQL Quality of Life Inventory 4.0 [ Time Frame: 29 days ] [ Designated as safety issue: No ]
- Fatigue as measured by the PedsQL Multidimensional Fatigue Scale [ Time Frame: 29 days ] [ Designated as safety issue: No ]
- Adverse events [ Time Frame: 29 days ] [ Designated as safety issue: Yes ]
| Enrollment: | 4 |
| Study Start Date: | July 2010 |
| 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:
|
|
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.
|
Other: placebo
Given orally
|
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 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 More Information
Additional 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 |
| Last Updated: | May 20, 2013 |
| 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 Sleep Disorders Parasomnias Central Nervous System Neoplasms Signs and Symptoms Neoplasms by Site Neoplasms Nervous System Diseases Neurologic Manifestations Mental Disorders 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 May 23, 2013