Transdermal Methylphenidate for Cancer-Related Fatigue
|ClinicalTrials.gov Identifier: NCT01124500|
Recruitment Status : Withdrawn
First Posted : May 17, 2010
Last Update Posted : August 26, 2010
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: methylphenidate via transdermal patch compared to placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Efficacy and Safety of Transdermal Methylphenidate for Cancer-Related Fatigue|
|Study Start Date :||May 2010|
|Estimated Primary Completion Date :||May 2012|
|Estimated Study Completion Date :||May 2012|
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.
- To investigate the efficacy of sustained-release, transdermal methylphenidate compared to a placebo. [ Time Frame: 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. [ Time Frame: for 10 days ]In adult head and neck cancer patients with fatigue.
- 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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01124500
|Principal Investigator:||Natalie Moryl, MD||Memorial Sloan Kettering Cancer Center|