Transdermal Methylphenidate for Cancer-Related Fatigue

Head and Neck Cancer Clinical Trial

Official title:

Efficacy and Safety of Transdermal Methylphenidate for Cancer-Related Fatigue

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01124500
• Other study ID #: 10-020
• Status: Withdrawn
• Phase: N/A
• First received: May 13, 2010
• Last updated: August 25, 2010
• Start date: May 2010
• Est. completion date: May 2012

Study information

• Verified date: August 2010
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	To evaluate the possible side effects of a methylphenidate patch.	In adult head and neck cancer patients with fatigue.	for 10 days	Yes
Secondary	To evaluate the feasibility of accelerometry-based objective outcome measures to assess improved activity levels and energy expenditure of cancer patients.	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.	for 10 days	No

External Links

•   Memorial Sloan-Kettering Cancer Center