Clinical trial NCT01773837: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Asthenia
Keywords: asthenia
advanced cancer
randomized controlled trial
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
First posted: 2013-01-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Intensity of asthenia assessed with the verbal numeric scale (VNS) included on the Edmonton Symptom Assessment System (ESAS)
timeFrame: After six days of therapy
Secondary outcomes:
measure: Intensity of asthenia assessed with the subscale for fatigue of the Functional Assessment of Cancer Therapy (FACT-F)
timeFrame: After six days of therapy
measure: 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).
timeFrame: After three and six days of therapy
measure: Intensity of other symptoms assessed with the Edmonton Symptom Assessment System (ESAS)
timeFrame: After three and six days of treatment
measure: Number of participants with treatment-related adverse events and severity of these adverse events.
timeFrame: After three and six days of treatment
measure: Cognitive level.
timeFrame: After three and six days of treatment
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
state: Navarra
Study officials:
affiliation: Clinica Universidad de Navarra
name: Carlos Centeno Cortes, MD, Phd
role: STUDY_CHAIR
References: