Transdermal Methylphenidate for Cancer-Related Fatigue

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01124500
First received: May 13, 2010
Last updated: August 25, 2010
Last verified: August 2010
  Purpose

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.


Condition Intervention
Head and Neck Cancer
Drug: methylphenidate via transdermal patch compared to placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Transdermal Methylphenidate for Cancer-Related Fatigue

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • To investigate the efficacy of sustained-release, transdermal methylphenidate compared to a placebo. [ Time Frame: for 10 days ] [ Designated as safety issue: No ]
    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. [ Time Frame: for 10 days ] [ Designated as safety issue: Yes ]
    In adult head and neck cancer patients with fatigue.


Secondary Outcome Measures:
  • To evaluate the feasibility of accelerometry-based objective outcome measures to assess improved activity levels and energy expenditure of cancer patients. [ Time Frame: for 10 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 0
Study Start Date: May 2010
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Drug: methylphenidate via transdermal patch compared to placebo
The participants will start with a 10mg MPH patch on day -4, the 1st day of the titration period. This will be increased up to 20mg over 4-day titration period as needed and tolerated, and continued on the optimal dose. Subjects will be seen on day 1 of the double-blind part of the study at a patient education room or the Dr.'s office and receive 10 identical patches including 5 MPH and 5 placebo patches that will be randomly assigned over the 10-day course. The patch will be placed at 9am and removed at 4pm daily for 10 days. During the 10 days, each subject will be monitored for continuous 240 hours by actigraphy based activity monitors to follow activity levels and energy expenditure.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01124500

Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Natalie Moryl, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Natalie Moryl, MD, Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01124500     History of Changes
Other Study ID Numbers: 10-020
Study First Received: May 13, 2010
Last Updated: August 25, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
methylphenidate
transdermal patch
placebo
fatigue
10-020

Additional relevant MeSH terms:
Fatigue
Head and Neck Neoplasms
Signs and Symptoms
Neoplasms by Site
Neoplasms
Methylphenidate
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 21, 2014