AstheniaPhase 3NCT01773837
Clinical Trial to Evaluate Short-term Efficacy of Palliative Methylphenidate in Asthenia in Advanced Cancer Patients
A Phase 3 study testing methylphenidate in people with Asthenia, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
Trial summary
Fatigue is the most prevalent symptom in advanced cancer patients, interfering functional capacity, social relations, wellbeing, and quality of life. Methylphenidate is a central nervous system stimulant that has traditionally been used in cancer patients to manage depression, opioid-induced sedation, hypoactive… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthenia
- What is being tested?
- methylphenidate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2012to Feb 2018
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced cancer; including metastatic, locally advanced or relapsed not amenable for curative treatment.
- Mini.mental status examination results within normal limits.
- Informed consent.
- Estimated life expectancy of at least one month.
- Hemoglobin >= 9 g/dl.
- Asthenia >= 5 (0-10; numeric verbal scale).
Who cannot join
- History of psychosis.
- Structured suicidal ideation.
- Severe anxiety.
- Severe renal, hepatic or cardiac (arrythmia, hypertension, ischemic heart disease) failure.
- Simultaneous treatment with drugs that may interact with methylphenidate as: coumarinics, anticonvulsivants (phenobarbital, phenitoin, primidone), phenylbutazone, inhibitors of mono-amine-oxidase, guanethidine.
- History of glaucoma.
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- Hyperthyroidism.
- History of hypersensibility to methylphenidate.
- Clinical suspicion of: infection, hypercalcemia, hypothyroidism or renal failure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind, Placebo-controlled, Multicenter Randomized Clinical Trial to Evaluate Short-term Efficacy of Palliative Treatment With Methylphenidate in Asthenia in Advanced Cancer Patients
Fatigue is the most prevalent symptom in advanced cancer patients, interfering functional capacity, social relations, wellbeing, and quality of life. Methylphenidate is a central nervous system stimulant that has traditionally been used in cancer patients to manage depression, opioid-induced sedation, hypoactive delirium due to multiorgan failure, and cognitive disorder associated with brain tumors. Although there is evidence from prospective studies of the efficacy of this drug in cancer-related fatigue, the only one randomised clinical trials gave non-conclusive results. In order to define the real efficacy of methylphenidate in this setting, the investigators designed a new clinical trial comparing methylphenidate and placebo in cancer-related fatigue, assessed both by the verbal numeric scale (VNS) included in the Edmonton Symptom Assessment System (ESAS) and the subscale for fatigue of the Functional Assessment of Cancer Therapy (FACT-F). The investigators will include 122 advanced cancer patients with fatigue ≥ 5/10 (VNS, from 0 to 10) and hemoglobin ≥ 9 g/dl. Patients will be randomized to methylphenidate or placebo. Doses will be adapted to response within a range from 10 mg at morning time and 5 at noon, to 25 mg/day. Assessment of response will be performed on day 3 and day 6 with ESAS and FACT-F. Drug-induced adverse events will be checked. The VNS of fatigue on day 6 will be consider the primary endpoint.
- Conditions
- Asthenia
- Being tested
- methylphenidate, placebo
- Keywords
- asthenia, advanced cancer, randomized controlled trial
- Medical subject headings
- Asthenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methylphenidateDrug
methylphenidate (pill) p.o. 15 to 25 mg daily for six days
placeboDrug
placebo (pill) p.o.
| Study group | Role | What they receive |
|---|---|---|
| methylphenidate | Experimental | methylphenidate (pill) p.o. 15 to 25 mg daily for six days Receives: Drug: methylphenidate |
| placebo | Placebo comparator | the same number of pills (p.o.) than methylphenidate for six days Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of asthenia assessed with the verbal numeric scale (VNS) included on the Edmonton Symptom Assessment System (ESAS)
We are looking for a difference between goups (methylphenidate versus placebo) of 1.5 (numeric rating scale: o to 10)
Measured: After six days of therapy
Secondary outcomes (5)
Intensity of asthenia assessed with the subscale for fatigue of the Functional Assessment of Cancer Therapy (FACT-F)
Measured: After six days of therapy
Intensity of asthenia assessed with the verbal numeric scale (VNS) included on the Edmonton Symptom Assessment System (ESAS) and the subscale for fatigue of the Functional Assessment of Cancer Therapy (FACT-F).
Measured: After three and six days of therapy
Intensity of other symptoms assessed with the Edmonton Symptom Assessment System (ESAS)
Measured: After three and six days of treatment
Number of participants with treatment-related adverse events and severity of these adverse events.
We will check for methylphenidate-related adverse events as: restlessness, hyperactivity, hyporexia, nausea and vomiting, dry mouth, palpitations, sleep insomnia, cephalea, muscle cramps, tics, and any other adverse event that could be treatment-related according to investigator. We will include the severity of the adverse event (mild, moderate, or severe), the presumed relationship with treatment, the measured required to treat it, and the final outcome.
Measured: After three and six days of treatment
Cognitive level.
We use a specific questionnaire. In order to facilitate its use in fatigued patients it is designed with a limited number of items selected from three validated tools as MMSE, 3MS, and RBANS
Measured: After three and six days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study startJan 2012
- Primary completionFeb 2018 (estimated)
- Study completionFeb 2018 (estimated)
Why it stopped: Slow accrual. 100 patients included
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AstheniaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos Centeno Cortes, MD, Phd, Study chair, Clinica Universidad de Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01773837
- Sponsor's protocol ID
- METILAS
- Other IDs
- 2008-002171-27, 2008
- Status last verified
- Aug 2013
- First submitted
- 8 Oct 2012
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Placebo-controlled, Multicenter Randomized Clinical Trial to Evaluate Short-term Efficacy of Palliative Treatment With Methylphenidate in Asthenia in Advanced Cancer Patients
- ClinicalTrials.gov ID
- NCT01773837
- Acronym / sponsor ID
- METILAS
- Conditions
- Asthenia
- Keywords
- asthenia, advanced cancer, randomized controlled trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual. 100 patients included
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 23 Jan 2013 (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.
Fatigue is the most prevalent symptom in advanced cancer patients, interfering functional capacity, social relations, wellbeing, and quality of life. Methylphenidate is a central nervous system stimulant that has traditionally been used in cancer patients to manage depression, opioid-induced sedation, hypoactive delirium due to multiorgan failure, and cognitive disorder associated with brain tumors. Although there is evidence from prospective studies of the efficacy of this drug in cancer-related fatigue, the only one randomised clinical trials gave non-conclusive results. In order to define the real efficacy of methylphenidate in this setting, the investigators designed a new clinical trial comparing methylphenidate and placebo in cancer-related fatigue, assessed both by the verbal numeric scale (VNS) included in the Edmonton Symptom Assessment System (ESAS) and the subscale for fatigue of the Functional Assessment of Cancer Therapy (FACT-F). The investigators will include 122 advanced cancer patients with fatigue ≥ 5/10 (VNS, from 0 to 10) and hemoglobin ≥ 9 g/dl. Patients will be randomized to methylphenidate or placebo. Doses will be adapted to response within a range from 10 mg at morning time and 5 at noon, to 25 mg/day. Assessment of response will be performed on day 3 and day 6 with ESAS and FACT-F. Drug-induced adverse events will be checked. The VNS of fatigue on day 6 will be consider the primary endpoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| methylphenidate | Experimental | Drug: methylphenidatemethylphenidate (pill) p.o. 15 to 25 mg daily for six days |
| placebo | Placebo comparator | Drug: placebothe same number of pills (p.o.) than methylphenidate for six days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Advanced cancer; including metastatic, locally advanced or relapsed not amenable for curative treatment.
- Mini.mental status examination results within normal limits.
- Informed consent.
- Estimated life expectancy of at least one month.
- Hemoglobin >= 9 g/dl.
Key exclusion criteria (9 listed)
- History of psychosis.
- Structured suicidal ideation.
- Severe anxiety.
- Severe renal, hepatic or cardiac (arrythmia, hypertension, ischemic heart disease) failure.
- Simultaneous treatment with drugs that may interact with methylphenidate as: coumarinics, anticonvulsivants (phenobarbital, phenitoin, primidone), phenylbutazone, inhibitors of mono-amine-oxidase, guanethidine.
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 |
|---|---|---|
| methylphenidatemethylphenidate (pill) p.o. 15 to 25 mg daily for six days | Drug | methylphenidate |
| placeboplacebo (pill) p.o. | Drug | placebo |
Primary outcome
Intensity of asthenia assessed with the verbal numeric scale (VNS) included on the Edmonton Symptom Assessment System (ESAS)
Time frame: After six days of therapy
We are looking for a difference between goups (methylphenidate versus placebo) of 1.5 (numeric rating scale: o to 10)
5 secondary outcomes
Intensity of asthenia assessed with the subscale for fatigue of the Functional Assessment of Cancer Therapy (FACT-F)
Time frame: After six days of therapy
Intensity of asthenia assessed with the verbal numeric scale (VNS) included on the Edmonton Symptom Assessment System (ESAS) and the subscale for fatigue of the Functional Assessment of Cancer Therapy (FACT-F).
Time frame: After three and six days of therapy
Intensity of other symptoms assessed with the Edmonton Symptom Assessment System (ESAS)
Time frame: After three and six days of treatment
Number of participants with treatment-related adverse events and severity of these adverse events.
Time frame: After three and six days of treatment
Cognitive level.
Time frame: After three and six days of treatment
Results and safety
The study was stopped early (reason given: Slow accrual. 100 patients included). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Individual participant dataSharing planned: Undecided
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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.
Carlos Centeno Cortes, MD, Phd study chair
Clinica Universidad de Navarra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing methylphenidate in people with Asthenia, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
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 6 inclusion and 9 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: stopped early, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow accrual. 100 patients included). Results are not available in the source record.
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?
Intensity of asthenia assessed with the verbal numeric scale (VNS) included on the Edmonton Symptom Assessment System (ESAS) (time frame: After six days of therapy). 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 9 May 2017.