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

Brief Title

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

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

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.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Intensity of asthenia assessed with the verbal numeric scale (VNS) included on the Edmonton Symptom Assessment System (ESAS)

Secondary Outcome

 Intensity of asthenia assessed with the subscale for fatigue of the Functional Assessment of Cancer Therapy (FACT-F)

Condition

Asthenia

Intervention

methylphenidate

Study Arms / Comparison Groups

 methylphenidate
Description:  methylphenidate (pill) p.o. 15 to 25 mg daily for six days

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

100

Start Date

January 2012

Completion Date

February 2018

Primary Completion Date

February 2018

Eligibility 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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Carlos Centeno Cortes, MD, Phd, , 

Location Countries

Spain

Location Countries

Spain

Administrative Informations


NCT ID

NCT01773837

Organization ID

METILAS

Secondary IDs

2008-002171-27

Responsible Party

Sponsor

Study Sponsor

Clinica Universidad de Navarra, Universidad de Navarra


Study Sponsor

Carlos Centeno Cortes, MD, Phd, Study Chair, Clinica Universidad de Navarra


Verification Date

August 2013