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Trial record 41 of 441 for:    Methylphenidate

Transdermal Methylphenidate for Cancer-Related Fatigue

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ClinicalTrials.gov Identifier: NCT01124500
Recruitment Status : Withdrawn
First Posted : May 17, 2010
Last Update Posted : August 26, 2010
Sponsor:
Information provided by:
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE May 13, 2010
First Posted Date  ICMJE May 17, 2010
Last Update Posted Date August 26, 2010
Study Start Date  ICMJE May 2010
Estimated Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2010)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01124500 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2010)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transdermal Methylphenidate for Cancer-Related Fatigue
Official Title  ICMJE Efficacy and Safety of Transdermal Methylphenidate for Cancer-Related Fatigue
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Head and Neck Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE 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
Intervention: Drug: methylphenidate via transdermal patch compared to placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: August 25, 2010)
0
Original Estimated Enrollment  ICMJE
 (submitted: May 13, 2010)
20
Estimated Study Completion Date  ICMJE May 2012
Estimated Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT01124500
Other Study ID Numbers  ICMJE 10-020
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Natalie Moryl, MD, Memorial Sloan-Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Natalie Moryl, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP