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

NCT01773837 | Terminated Phase 3

• 2 other identifiers: METILAS2008-002171-27
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthenia

Keywords

asthenia; advanced cancer; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Intensity of asthenia assessed with the subscale for fatigue of the Functional Assessment of Cancer Therapy (FACT-F)

  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).

  After three and six days of therapy

• Intensity of other symptoms assessed with the Edmonton Symptom Assessment System (ESAS)

  After three and six days of treatment

• Number of participants with treatment-related adverse events and severity of these adverse events.

  After three and six days of treatment

• Cognitive level.

  After three and six days of treatment

Study Arms (2)

methylphenidate

EXPERIMENTAL

methylphenidate (pill) p.o. 15 to 25 mg daily for six days

Drug: methylphenidate

placebo

PLACEBO COMPARATOR

the same number of pills (p.o.) than methylphenidate for six days

Drug: placebo

Interventions

methylphenidate DRUG

methylphenidate (pill) p.o. 15 to 25 mg daily for six days

methylphenidate

placebo DRUG

placebo (pill) p.o.

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead

Study Sites (1)

Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

MeSH Terms

Conditions

Asthenia

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Carlos Centeno Cortes, MD, Phd

  Clinica Universidad de Navarra

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2012
• First Posted: January 23, 2013
• Study Start: January 1, 2012
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: May 9, 2017

Record last verified: 2013-08

Locations

ES (1)