Methylphenidate Hydrochloride or Modafinil in Treating Young Patients With Excessive Daytime Sleepiness After Cancer Therapy
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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 Masking: Double-Blind 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 as measured by actigraphy [ Designated as safety issue: No ]
- Improvement in symptoms associated with excessive daytime sleepiness as measured by the Cleveland Adolescent Sleepiness Questionnaire or Pediatric Daytime Sleepiness Scale [ Designated as safety issue: No ]
- Change in the average daily napping minutes from baseline to days 8-14 [ Designated as safety issue: No ]
- Quality of life as measured by the PedsQL Quality of Life Inventory 4.0 [ Designated as safety issue: No ]
- Fatigue as measured by the PedsQL Multidimensional Fatigue Scale [ Designated as safety issue: No ]
- Adverse events [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 135 |
| Study Start Date: | July 2010 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients receive oral methylphenidate extended-release once daily for 7-42 days in the absence of unacceptable toxicity.
|
Drug: methylphenidate hydrochloride
Given orally
|
|
Experimental: Arm II
Patients receive oral modafinil once daily for 7-42 days in the absence of unacceptable toxicity.
|
Drug: modafinil
Given orally
|
|
Placebo Comparator: Arm III
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 25 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Previously treated for one of the following:
- Hypothalamic tumor
- Mid-line brain tumor
- Tumor involving one or both thalami
- Craniopharyngioma
- Hydrocephalus secondary to a brain tumor or brain tumor that required placement of a permanent shunt
- Completed cancer treatment ≥ 6 months ago
Has excessive daytime sleepiness (EDS), as defined by a score of > 0.33 on the Extended Daytime Sleepiness subscale of the Pediatric Sleepiness Questionnaire (PSQ) AND a score of ≤ 0.33 on the Sleep-Related Breathing Disorders subscale of the PSQ
Has had symptoms of EDS for ≥ 3 months that are not a result of inadequate sleep hygiene or other medical disorder, as measured by either of the following:
- Score ≥ 20 on the Pediatric Daytime Sleepiness Scale (for patients 8-10 years of age)
- Score ≥ 43 on the Cleveland Adolescent Sleepiness Questionnaire (for patients 11-17 years of age)
- No diagnosis of attention-deficit hyperactivity disorder or EDS prior to receiving cancer treatment
PATIENT CHARACTERISTICS:
- Proficient in English
- Able to swallow capsules
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception
- No history of a clinically significant drug sensitivity to methylphenidate, modafinil, armodafinil, or any of their components
No know cardiac disorders, including any of the following:
- Arrhythmias
- Hypertension requiring treatment
- Structural heart disease
- No clinical diagnosis of major depression, subclinical depression, or anxiety disorder
- No history of psychosis or mania
- No suicidal ideation
- No history of substance abuse
- No anemia, untreated hypothyroidism, mononucleosis, or narcolepsy
- No total dietary intake of > 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 of chocolate per day)
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior doxorubicin hydrochloride or high-dose cyclophosphamide
- More than 90 days since prior methylphenidate or modafinil
- No concurrent antihistamines, benzodiazepines, anticonvulsants, or alcohol
- No concurrent oral birth control for contraception
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Viki Huegel, SunCoast CCOP Research Base at the University of South Florida |
| ClinicalTrials.gov Identifier: | NCT01348607 History of Changes |
| Other Study ID Numbers: | CDR0000654435, SCUSF-0803, HLMCC-0803 |
| Study First Received: | May 4, 2011 |
| Last Updated: | December 11, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by National Cancer Institute (NCI):
|
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 16, 2013