Transdermal Methylphenidate for Cancer-Related Fatigue

NCT01124500 | Withdrawn

• 1 other identifier: 10-020
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Head and Neck Cancer

Keywords

methylphenidate; transdermal patch; placebo; fatigue; 10-020

Outcome Measures

Primary Outcomes (2)

• To investigate the efficacy of sustained-release, transdermal methylphenidate compared to a placebo.

  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.

  for 10 days

• To evaluate the possible side effects of a methylphenidate patch.

  In adult head and neck cancer patients with fatigue.

  for 10 days

Secondary Outcomes (1)

• To evaluate the feasibility of accelerometry-based objective outcome measures to assess improved activity levels and energy expenditure of cancer patients.

  for 10 days

Study Arms (1)

methylphenidate via transdermal patch compared to placebo

EXPERIMENTAL

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

Interventions

methylphenidate via transdermal patch compared to placebo DRUG

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.

methylphenidate via transdermal patch compared to placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Head and Neck Neoplasms; Fatigue

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Natalie Moryl, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 13, 2010
• First Posted: May 17, 2010
• Study Start: May 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: August 26, 2010

Record last verified: 2010-08