Clinical Trial to Evaluate Short-term Efficacy of Palliative Methylphenidate in Asthenia in Advanced Cancer Patients
Status:
Terminated
Trial end date:
2018-02-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Clinica Universidad de Navarra, Universidad de Navarra