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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Clinica Universidad de Navarra, Universidad de Navarra
Sponsor:
Information provided by (Responsible Party):
Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier:
NCT01773837
First received: October 8, 2012
Last updated: August 8, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Asthenia
Drug: methylphenidate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Clinica Universidad de Navarra, Universidad de Navarra:

Primary Outcome Measures:
  • Intensity of asthenia assessed with the verbal numeric scale (VNS) included on the Edmonton Symptom Assessment System (ESAS) [ Time Frame: After six days of therapy ] [ Designated as safety issue: No ]
    We are looking for a difference between goups (methylphenidate versus placebo) of 1.5 (numeric rating scale: o to 10)


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Intensity of other symptoms assessed with the Edmonton Symptom Assessment System (ESAS) [ Time Frame: After three and six days of treatment ] [ Designated as safety issue: No ]
  • Number of participants with treatment-related adverse events and severity of these adverse events. [ Time Frame: After three and six days of treatment ] [ Designated as safety issue: Yes ]
    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.

  • Cognitive level. [ Time Frame: After three and six days of treatment ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 122
Study Start Date: January 2012
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: methylphenidate
methylphenidate (pill) p.o. 15 to 25 mg daily for six days
Drug: methylphenidate
methylphenidate (pill) p.o. 15 to 25 mg daily for six days
Placebo Comparator: placebo
the same number of pills (p.o.) than methylphenidate for six days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01773837

Contacts
Contact: Carlos Centeno Cortes, MD PhD 3448255500 ccenteno@unav.es

Locations
Spain
Clinica Universidad de Navarra Recruiting
Pamplona, Navarra, Spain, 31008
Principal Investigator: Carlos Centeno, Cotes         
Sponsors and Collaborators
Clinica Universidad de Navarra, Universidad de Navarra
Investigators
Study Chair: Carlos Centeno Cortes, MD, Phd Clinica Universidad de Navarra
  More Information

No publications provided

Responsible Party: Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier: NCT01773837     History of Changes
Other Study ID Numbers: METILAS, 2008-002171-27
Study First Received: October 8, 2012
Last Updated: August 8, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Clinica Universidad de Navarra, Universidad de Navarra:
asthenia
advanced cancer
randomized controlled trial

Additional relevant MeSH terms:
Asthenia
Neoplasms
Signs and Symptoms
Methylphenidate
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014