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Trial record 54 of 439 for:    Methylphenidate

Ritalin: Antiasthenic Effect of Methylphenidate (Ritalin) in Palliative Care in Cancer Patients (Ritaline)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00273741
Recruitment Status : Terminated (difficulty of recrutement)
First Posted : January 9, 2006
Last Update Posted : December 7, 2009
Fondation de France
Ligue contre le cancer, France
Information provided by:
University Hospital, Grenoble

Brief Summary:
The aim/objective of this study is to evaluate the antiasthenic effect of methylphenidate with a visual analogical scale (VAS) after 7 days of treatment, in cancer patients, in palliative care, i.e. with a progressive or terminal disease.

Condition or disease Intervention/treatment Phase
Asthenia Neoplasms Drug: methylphenidate Drug: placebo comparator Phase 3

Detailed Description:

Cancer patients in an advanced phase or who are terminally ill generally present with depression, pain, drowsiness, alterations of cognition, anorexia and other symptoms due to the progressive disease. The objective of the medical team of support and palliative care is to control these effects to maintain a quality of life. Particularly, the cancer patient in an advanced phase of the disease presents with important asthenia. In some patients, this asthenia is characterized by drowsiness or apathy. It always leads to ill-being and a sensation of bad adaptation. When an etiologic treatment is possible (correction of the anaemia, of the metabolic disorders, of the undernutrition, of the anorexia, of the insomnia, of the stubborn pain, of the psychological suffering), the asthenia can be fought. But, when it appears in patients not really in the end of life (life expectancy more than 1 month) and when no etiologic treatments are possible, other solutions must be considered, and all the more when the complaint is important with repeated requests for relief.

Methylphenidate is an amphetamine first indicated for deficient attention disorders with hyperactivity in children more than 6 years old. Several studies have been realized to evaluate its effect in cancer patients in palliative care. Some studies showed, in particular, its effectiveness on asthenia because of a stimulant and an antidepressant action. The methylphenidate could have an anti-analgesic effect or co-analgesic effect. All these studies are observational and not randomized. So they have a small level of proof and they have not been realized in a population of asthenic patients in palliative care. So a randomized controlled clinical trial in this specific population needs to be experimented.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Study Evaluating the Antiasthenic Effect of Methylphenidate (Ritalin) in Palliative Care in Cancer Patients
Study Start Date : January 2007
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Arm Intervention/treatment
Experimental: 1
methylphenidate at 20mg per day during 7 days, at 20mg or 40mg per day during 7 days and 20, 40 or 60mg per day during 14 days
Drug: methylphenidate
methylphenidate per os 20mg per day 7 days, 20mg or 40mg per day 7 days and 20, 40 or 60mg per day 14 days
Other Name: active

Placebo Comparator: 2
placebo capsules
Drug: placebo comparator
placebo capsules
Other Name: placebo

Primary Outcome Measures :
  1. Reduction of 3 units between the two study groups of the subjective impression of asthenia measured at the first day before the beginning of the treatment with a visual analogical scale at day 7 (+/- 1 day) [ Time Frame: 7 days AVS ]

Secondary Outcome Measures :
  1. Adverse events [ Time Frame: each day ]
  2. Visual analogical scale of pain [ Time Frame: inclusion, day 1, 2, 3, 7, 14 and 28 ]
  3. European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 [ Time Frame: day 1, 7 and 28 ]
  4. Multidimensional Fatigue Inventory-20 (MFI-20) [ Time Frame: day 1, 7, 14 and 28 ]
  5. Hospital Anxiety and Depression Scale (HADS) [ Time Frame: inclusion, 7 and 28 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Advanced phase of neoplasm without any treatment available.
  • Life expectancy of more than 1 month
  • Karnofsky index more than 50%
  • Chemotherapy IV or immunotherapy SC stopped more than 3 weeks before the end of the study
  • Asthenia more than 5/10 on the visual analogical scale
  • Informed consent form signed
  • Affiliation to social security

Exclusion Criteria:

  • Patients who can receive chemotherapy IV or immunotherapy SC in the month following the study
  • Patients in whom disease can respond to chemotherapy
  • Corticotherapy started less than 7 days before the study or potentially within the first week of the study
  • Asthenia which can be easily corrected
  • Contraindications to the amphetamines
  • HADS score of anxiety and/or depression more than or egal to 17/21
  • Potential surgery with general anesthesia in the first 7 days of the study
  • Inability to quantify the sensation of asthenia on the visual analogical scale
  • Pregnancy or feeding
  • Guardianship

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00273741

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Hôpital D'Annemasse
Annemasse, France, 74107
Centre Régional d'Accompagnement et de Soins Palliatifs,
Bordeaux, France, 33000
Equipe mobile de recherche et de soutien en soins pallitaifs
Grenoble, France, 38043
Unité de Soins palliatif, Centre Oscar Lambret
Lille, France, 59000
Unité de Soins Palliatifs, Hôpital Lyon sud
Lyon, France, 69000
Soins Palliatifs et Soins de support, Centre Léon Bérard, 28 rue Laënnec,
Lyon, France, 69373
Unité mobile de soutien et de soins palliatifs, Hôpital Saint-Eloi
Montpellier, France, 34295
EMSP, Institut Curie
Paris, France, 75005
EMSP, hôpital Saint aAntoine
Paris, France, 75012
Passy, France, 74190
Unité de Soins Palliatifs
Saint-Etienne, France, 42055
EMSP, Hôpitaux du Léman
Thonon-les-bains, France, 74203
Institut Gustave Roussy
Villejuif, France, 94805
Sponsors and Collaborators
University Hospital, Grenoble
Fondation de France
Ligue contre le cancer, France
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Principal Investigator: Guillemette Laval, M.D., Ph.D. University Hospital, Grenoble

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Responsible Party: Mr Marie, Direction de la recherche clinique et de l'innovation Identifier: NCT00273741     History of Changes
Other Study ID Numbers: DCIC 03 29
First Posted: January 9, 2006    Key Record Dates
Last Update Posted: December 7, 2009
Last Verified: December 2009
Keywords provided by University Hospital, Grenoble:
palliative care
Additional relevant MeSH terms:
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Signs and Symptoms
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents