Transdermal Methylphenidate for Cancer-Related Fatigue

Memorial Sloan Kettering Cancer Center (MSK)

Status: Withdrawn

Conditions: Head and Neck Cancer

Treatments: Drug: methylphenidate via transdermal patch compared to placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01124500

10-020

Details and patient eligibility

About

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.

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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0 participants in 1 patient group

methylphenidate via transdermal patch compared to placebo

Experimental group

Description:

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

Treatment:

Drug: methylphenidate via transdermal patch compared to placebo