Asthenia | Clinical Trial to Evaluate Short-term Efficacy of Palliative Methylphenidate in Asthenia in Advanced Cancer Patients
Asthenia research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:methylphenidatemethylphenidate (pill) p.o. 15 to 25 mg daily for six days
Drug:placeboplacebo (pill) p.o.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
methylphenidatemethylphenidate (pill) p.o. 15 to 25 mg daily for six days
placebothe same number of pills (p.o.) than methylphenidate for six days
Start Date: January 2012
Completed Date: February 2018
Phase: Phase 3
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)
Study sponsors, principal investigator, and references
Principal Investigator: Carlos Centeno Cortes, MD, Phd
Lead Sponsor: Clinica Universidad de Navarra, Universidad de Navarra