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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Status: Withdrawn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

Page last updated: August 23, 2015

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