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Transdermal Methylphenidate for Cancer-Related Fatigue

NCT01124500 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2010-08-26

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Natalie Moryl, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2012-05-31
Completion
2012-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01124500 on ClinicalTrials.gov