Head and Neck CancerNCT01124500
Transdermal Methylphenidate for Cancer-Related Fatigue
A study of Head and Neck Cancer, run by Memorial Sloan Kettering Cancer Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Head and Neck Cancer
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2010to May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
About this study
Official title: Efficacy and Safety of Transdermal Methylphenidate for Cancer-Related Fatigue
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
- Head and Neck Cancer
- Being tested
- methylphenidate via transdermal patch compared to placebo
- Keywords
- methylphenidate, transdermal patch, placebo, fatigue, 10-020
- Medical subject headings
- Head and Neck Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methylphenidate via transdermal patch compared to placeboDrug
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 group | Role | What they receive |
|---|---|---|
| methylphenidate via transdermal patch compared to placebo | Experimental | 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 Receives: Drug: methylphenidate via transdermal patch compared to placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: for 10 days
To evaluate the possible side effects of a methylphenidate patch.
In adult head and neck cancer patients with fatigue.
Measured: for 10 days
Secondary outcomes (1)
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.
Measured: for 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2010 (estimated)
- Study startMay 2010
- Primary completionMay 2012 (estimated)
- Study completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Investigators
- Natalie Moryl, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01124500
- Sponsor's protocol ID
- 10-020
- Status last verified
- Aug 2010
- First submitted
- 13 May 2010
- Last updated
- 26 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Transdermal Methylphenidate for Cancer-Related Fatigue
- ClinicalTrials.gov ID
- NCT01124500
- Acronym / sponsor ID
- 10-020
- Conditions
- Head and Neck Cancer
- Keywords
- methylphenidate, transdermal patch, placebo, fatigue, 10-020
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- May 2012 (estimated)
- Study completion
- May 2012 (estimated)
- First posted
- 17 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| methylphenidate via transdermal patch compared to placebo | Experimental | Drug: methylphenidate via transdermal patch compared to placeboThe 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 |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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 )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| methylphenidate via transdermal patch compared to placeboThe 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. | Drug | methylphenidate via transdermal patch compared to placebo |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2010.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natalie Moryl, MD principal investigator
Memorial Sloan Kettering Cancer Center
Questions about this trial
What is this clinical trial studying?
A study of Head and Neck Cancer, run by Memorial Sloan Kettering Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the efficacy of sustained-release, transdermal methylphenidate compared to a placebo. (time frame: for 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2010.