Efficacy and Safety of Transdermal Methylphenidate for Cancer-Related Fatigue
21 Years
N/A
Both
Head and Neck Cancer
Trial Information
Efficacy and Safety of Transdermal Methylphenidate for Cancer-Related Fatigue
Inclusion Criteria:
- Diagnosis of head and neck cancer who underwent combined modality treatment with
curative intent
- Has not undergone cancer treatment in the last 4 weeks
- Is 21 years of age or older
- Fatigue scale score of 4 or higher
- Is able to understand English, through written and verbal communication
- In the judgment of the consenting professional, is able to provide informed consent
- Physically able to present for follow-up appointments at outpatient Radiation
Oncology or Pain & Palliative Care clinics
- Probable life expectancy of more than 6 months
Exclusion Criteria:
- Pulmonary or cardiovascular failure, seizure disorder, sleep disorder, mental
impairment, psychiatric disorder, or pregnancy
- Has known sensitivity or allergies to methylphenidate
- Receiving concurrent treatment with a psychostimulant
- Hospitalized patients
- Evidence of impaired hepatic or renal function (hyperbilirubinemia, greater than two
fold elevation of transaminases; >40mg/dl BUN or >1.5mg/dl Cr )
- Anemia ( hemoglobin <10mg/dl)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
To investigate the efficacy of sustained-release, transdermal methylphenidate compared to a placebo.
Outcome Description:
In reducing fatigue, increasing activity levels, and sustaining steady wakefulness throughout the day. The outcome measure will be BFI and ESS based self-reporting of the reduction of numeric rating scale on fatigue level and sleepiness, combined with objective measurement of increased activity intensity scores monitored by actigraphy.
Outcome Time Frame:
for 10 days
Safety Issue:
No
Principal Investigator
Natalie Moryl, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
10-020
NCT ID:
NCT01124500
Start Date:
May 2010
Completion Date:
May 2012
Related Keywords:
- Head and Neck Cancer
- methylphenidate
- transdermal patch
- placebo
- fatigue
- 10-020
- Fatigue
- Head and Neck Neoplasms
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