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Clinical Trial to Evaluate Short-term Efficacy of Palliative Methylphenidate in Asthenia in Advanced Cancer Patients

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ClinicalTrials.gov Identifier: NCT01773837
Recruitment Status : Terminated (Slow accrual. 100 patients included)
First Posted : January 23, 2013
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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 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.

Condition or disease Intervention/treatment Phase
Asthenia Drug: methylphenidate Drug: placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : January 2012
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: methylphenidate
methylphenidate (pill) p.o. 15 to 25 mg daily for six days
Drug: methylphenidate
methylphenidate (pill) p.o. 15 to 25 mg daily for six days
Placebo Comparator: placebo
the same number of pills (p.o.) than methylphenidate for six days
Drug: placebo
placebo (pill) p.o.


Outcome Measures

Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Intensity of other symptoms assessed with the Edmonton Symptom Assessment System (ESAS) [ Time Frame: After three and six days of treatment ]
  4. Number of participants with treatment-related adverse events and severity of these adverse events. [ Time Frame: After three and six days of treatment ]
    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.

  5. Cognitive level. [ Time Frame: After three and six days of treatment ]
    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


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.
  • Hyperthyroidism.
  • History of hypersensibility to methylphenidate.
  • Clinical suspicion of: infection, hypercalcemia, hypothyroidism or renal failure.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01773837


Locations
Spain
Clinica Universidad de Navarra
Pamplona, Navarra, Spain, 31008
Sponsors and Collaborators
Clinica Universidad de Navarra, Universidad de Navarra
Investigators
Study Chair: Carlos Centeno Cortes, MD, Phd Clinica Universidad de Navarra
More Information

Responsible Party: Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier: NCT01773837     History of Changes
Other Study ID Numbers: METILAS
2008-002171-27 ( EudraCT Number )
First Posted: January 23, 2013    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: August 2013
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Clinica Universidad de Navarra, Universidad de Navarra:
asthenia
advanced cancer
randomized controlled trial

Additional relevant MeSH terms:
Asthenia
Signs and Symptoms
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents