Clinical Trial to Evaluate Short-term Efficacy of Palliative Methylphenidate in Asthenia in Advanced Cancer Patients

Asthenia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01773837
• Other study ID #: METILAS
• Secondary ID: 2008-002171-27
• Status: Terminated
• Phase: Phase 3
• First received: October 8, 2012
• Last updated: May 8, 2017
• Start date: January 2012
• Est. completion date: February 2018

Study information

• Verified date: August 2013
• Source: Clinica Universidad de Navarra, Universidad de Navarra
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthenia

Intervention

Drug:
• methylphenidate
methylphenidate (pill) p.o. 15 to 25 mg daily for six days
• placebo
placebo (pill) p.o.

Locations

Country	Name	City	State
Spain	Clinica Universidad de Navarra	Pamplona	Navarra

Sponsors (1)

Lead Sponsor	Collaborator
Clinica Universidad de Navarra, Universidad de Navarra

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	After six days of therapy
Secondary	Intensity of asthenia assessed with the subscale for fatigue of the Functional Assessment of Cancer Therapy (FACT-F)		After six days of therapy
Secondary	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).		After three and six days of therapy
Secondary	Intensity of other symptoms assessed with the Edmonton Symptom Assessment System (ESAS)		After three and six days of treatment
Secondary	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.	After three and six days of treatment
Secondary	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	After three and six days of treatment