A Phase 3 interventional study of methylphenidate and placebo in Asthenia, sponsored by Clinica Universidad de Navarra, Universidad de Navarra. Terminated at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-09.
Sponsored by Clinica Universidad de Navarra, Universidad de Navarra · Phase 3, Interventional, and Treatment
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.
119 studies on the registry are indexed under Asthenia; 25 are open to participants now.
This study's enrollment of 100 is above the median of 42 across 84 interventional studies indexed under Asthenia.
Browse Asthenia studies →Clinica Universidad de Navarra, Universidad de Navarra is the lead sponsor of 158 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
methylphenidate (pill) p.o. 15 to 25 mg daily for six days
Drug: methylphenidate
the same number of pills (p.o.) than methylphenidate for six days
Drug: placebo
methylphenidate (pill) p.o. 15 to 25 mg daily for six days
placebo (pill) p.o.
Intensity of asthenia assessed with the verbal numeric scale (VNS) included on the Edmonton Symptom Assessment System (ESAS)
We are looking for a difference between goups (methylphenidate versus placebo) of 1.5 (numeric rating scale: o to 10)
Time frame: After six days of therapy
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
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
Intensity of other symptoms assessed with the Edmonton Symptom Assessment System (ESAS)
Time frame: After three and six days of treatment
Number of participants with treatment-related adverse events and severity of these adverse events.
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.
Time frame: After three and six days of treatment
Cognitive level.
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
Time frame: After three and six days of treatment
Plan to share: Undecided
No publications or documents are linked to this record.
This study is terminated, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.
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Clinica Universidad de Navarra, Universidad de Navarra