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

U

University of Navarra

Status and phase

Terminated
Phase 3

Conditions

Asthenia

Treatments

Drug: methylphenidate
Drug: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01773837
METILAS
2008-002171-27 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

100 participants in 2 patient groups, including a placebo group

methylphenidate
Experimental group
Description:
methylphenidate (pill) p.o. 15 to 25 mg daily for six days
Treatment:
Drug: methylphenidate
placebo
Placebo Comparator group
Description:
the same number of pills (p.o.) than methylphenidate for six days
Treatment:
Drug: placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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