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Efficacy and Safety of Transdermal Methylphenidate for Cancer-Related Fatigue

21 Years
Not Enrolling
Head and Neck Cancer

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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:


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:


Principal Investigator

Natalie Moryl, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




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