Head and Neck Cancer
Conditions
Keywords
methylphenidate, transdermal patch, placebo, fatigue, 10-020
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.
Interventions
DRUGmethylphenidate 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
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To investigate the efficacy of sustained-release, transdermal methylphenidate compared to a placebo. | 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. | for 10 days | In adult head and neck cancer patients with fatigue. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the feasibility of accelerometry-based objective outcome measures to assess improved activity levels and energy expenditure of cancer patients. | 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. |
Outcome results
None listed