Transdermal Methylphenidate for Cancer-Related Fatigue
Information source: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Head and Neck Cancer
Intervention: methylphenidate via transdermal patch compared to placebo (Drug)
Phase: N/A
Status: Withdrawn
Sponsored by: Memorial Sloan Kettering Cancer Center Official(s) and/or principal investigator(s): Natalie Moryl, MD, Principal Investigator, Affiliation: Memorial Sloan Kettering Cancer Center
Summary
The purpose of this study is to compare the effects, good and/or bad, of the Methylphenidate
patch and a placebo patch (a patch that contains no medicine) on patients and their fatigue
caused by cancer or by cancer treatment. The Methylphenidate patch contains a medication
that is known to increase alertness and wakefulness. Oral methylphenidate has been used in
the past to treat cancer related fatigue and is often used to treat unusual sleepiness. But
this is the first time that the patch form is offered to try treating cancer fatigue in
patients who cannot always swallow tablets.
Clinical Details
Official title: Efficacy and Safety of Transdermal Methylphenidate for Cancer-Related Fatigue
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: To investigate the efficacy of sustained-release, transdermal methylphenidate compared to a placebo.To evaluate the possible side effects of a methylphenidate patch.
Secondary outcome: To evaluate the feasibility of accelerometry-based objective outcome measures to assess improved activity levels and energy expenditure of cancer patients.
Eligibility
Minimum age: 21 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
Additional Information
Memorial Sloan-Kettering Cancer Center
Starting date: May 2010
Last updated: August 25, 2010
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