Clinical trial · Interventional
Transdermal Methylphenidate for Cancer-Related Fatigue
Efficacy and Safety of Transdermal Methylphenidate for Cancer-Related Fatigue
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| methylphenidate via transdermal patch compared to placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- methylphenidate via transdermal patch compared to placebo
- 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
- interventionNames
- Drug: methylphenidate via transdermal patch compared to placebo
Primary outcomes (2)
- measure
- To investigate the efficacy of sustained-release, transdermal methylphenidate compared to a placebo.
- timeFrame
- for 10 days
- 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.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
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)
References
Publications (0)
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