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Transdermal Methylphenidate for Cancer-Related Fatigue

Primary Purpose

Head and Neck Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
methylphenidate via transdermal patch compared to placebo
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring methylphenidate, transdermal patch, placebo, fatigue, 10-020

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    methylphenidate via transdermal patch compared to placebo

    Arm Description

    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

    Outcomes

    Primary Outcome Measures

    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.
    To evaluate the possible side effects of a methylphenidate patch.
    In adult head and neck cancer patients with fatigue.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    May 13, 2010
    Last Updated
    August 25, 2010
    Sponsor
    Memorial Sloan Kettering Cancer Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01124500
    Brief Title
    Transdermal Methylphenidate for Cancer-Related Fatigue
    Official Title
    Efficacy and Safety of Transdermal Methylphenidate for Cancer-Related Fatigue
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2010
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    May 2010 (undefined)
    Primary Completion Date
    May 2012 (Anticipated)
    Study Completion Date
    May 2012 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Memorial Sloan Kettering Cancer Center

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Head and Neck Cancer
    Keywords
    methylphenidate, transdermal patch, placebo, fatigue, 10-020

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    methylphenidate via transdermal patch compared to placebo
    Arm Type
    Experimental
    Arm Description
    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 Type
    Drug
    Intervention Name(s)
    methylphenidate via transdermal patch compared to placebo
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    To investigate the efficacy of sustained-release, transdermal methylphenidate compared to a placebo.
    Description
    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.
    Time Frame
    for 10 days
    Title
    To evaluate the possible side effects of a methylphenidate patch.
    Description
    In adult head and neck cancer patients with fatigue.
    Time Frame
    for 10 days
    Secondary Outcome Measure Information:
    Title
    To evaluate the feasibility of accelerometry-based objective outcome measures to assess improved activity levels and energy expenditure of cancer patients.
    Description
    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.
    Time Frame
    for 10 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Natalie Moryl, MD
    Organizational Affiliation
    Memorial Sloan Kettering Cancer Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Links:
    URL
    http://www.mskcc.org
    Description
    Memorial Sloan-Kettering Cancer Center

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