Transdermal Methylphenidate for Cancer-Related Fatigue

Not Applicable

Withdrawn

• Conditions: Head and Neck Cancer
• Interventions: Drug: methylphenidate via transdermal patch compared to placebo

• Registration Number: NCT01124500
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-13
• Study First Submitted QC: 2010-05-13
• Study First Posted: 2010-05-17
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-25
• Last Update Posted: 2010-08-26
• Primary Completion: 2012-05
• Study Completion: 2012-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
methylphenidate via transdermal patch compared to placebo	methylphenidate via transdermal patch compared to placebo	The proposed study is a within-subject, cross-over, randomized and double-blinded pilot trial, designed to evaluate the efficacy and feasibility of sustained-release, long-acting methylphenidate via transdermal patch compared to placebo in fatigued patients with Head and Neck malignancies

Primary Outcome Measures

Name	Time	Method
To investigate the efficacy of sustained-release, transdermal methylphenidate compared to a placebo.	for 10 days	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.
To evaluate the possible side effects of a methylphenidate patch.	for 10 days	In adult head and neck cancer patients with fatigue.

Secondary Outcome Measures

Name	Time	Method
To evaluate the feasibility of accelerometry-based objective outcome measures to assess improved activity levels and energy expenditure of cancer patients.	for 10 days	To evaluate the feasibility of accelerometry-based objective outcome measures to assess improved activity levels and energy expenditure, will be evaluated by examining the patients' rating of their comfort while wearing the actigraphy device and of how willing they would be to wear the device for a future study.