Transdermal Methylphenidate for Cancer-Related Fatigue
This study has been withdrawn prior to enrollment.
Sponsor:
Memorial Sloan-Kettering Cancer Center
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01124500
First received: May 13, 2010
Last updated: August 25, 2010
Last verified: August 2010
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Head and Neck Cancer |
Drug: methylphenidate via transdermal patch compared to placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Efficacy and Safety of Transdermal Methylphenidate for Cancer-Related Fatigue |
Resource links provided by NLM:
Further study details as provided by Memorial Sloan-Kettering Cancer Center:
Primary Outcome Measures:
- To investigate the efficacy of sustained-release, transdermal methylphenidate compared to a placebo. [ Time Frame: for 10 days ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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. [ Time Frame: for 10 days ] [ Designated as safety issue: No ]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.
| Enrollment: | 0 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | May 2012 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Natalie Moryl, MD, Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01124500 History of Changes |
| Other Study ID Numbers: | 10-020 |
| Study First Received: | May 13, 2010 |
| Last Updated: | August 25, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
methylphenidate transdermal patch placebo fatigue 10-020 |
Additional relevant MeSH terms:
|
Fatigue Head and Neck Neoplasms Signs and Symptoms Neoplasms by Site Neoplasms Methylphenidate Dopamine Uptake Inhibitors Dopamine Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013