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Double-blind, Placebo-controlled, Multicenter Randomized Clinical Trial to Evaluate Short-term Efficacy of Palliative Treatment With Methylphenidate in Asthenia in Advanced Cancer Patients


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Asthenia

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Trial Information

Double-blind, Placebo-controlled, Multicenter Randomized Clinical Trial to Evaluate Short-term Efficacy of Palliative Treatment With Methylphenidate in Asthenia in Advanced Cancer Patients


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

We are looking for a difference between goups (methylphenidate versus placebo) of 1.5 (numeric rating scale: o to 10)

Outcome Time Frame:

After six days of therapy

Safety Issue:

No

Principal Investigator

Carlos Centeno Cortes, MD, Phd

Investigator Role:

Study Chair

Investigator Affiliation:

Clinica Universidad de Navarra

Authority:

Spain: Agencia EspaƱola de Medicamentos y Productos Sanitarios

Study ID:

METILAS

NCT ID:

NCT01773837

Start Date:

January 2012

Completion Date:

Related Keywords:

  • Asthenia
  • asthenia
  • advanced cancer
  • randomized controlled trial
  • Asthenia
  • Neoplasms

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