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Sponsors and Collaborators: |
University Hospital, Grenoble Fondation de France Ligue nationale Contre le Cancer |
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Information provided by: | University Hospital, Grenoble |
ClinicalTrials.gov Identifier: | NCT00273741 |
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 | Intervention | Phase |
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Asthenia Neoplasms |
Drug: methylphenidate Drug: placebo comparator |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Randomized Study Evaluating the Antiasthenic Effect of Methylphenidate (Ritalin) in Palliative Care in Cancer Patients |
Estimated Enrollment: | 110 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
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
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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
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2: Placebo Comparator
placebo capsules
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Drug: placebo comparator
placebo capsules
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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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Denis Moro-Sibillot, M.D., Ph.D. | 04-76-76-92-60 |
France | |
Equipe mobile de recherche et de soutien en soins pallitaifs | Recruiting |
GRENOBLE, France, 38043 | |
Contact: Guillemette Laval, M.D., Ph.D. | |
Sub-Investigator: Marie-Laure Villard | |
Principal Investigator: Guillemette Laval, Dr | |
Sub-Investigator: Nicolas BEZIAUD, Dr | |
Sub-Investigator: Virginie Noël, Dr | |
Soins Palliatifs et Soins de support, Centre Léon Bérard, 28 rue Laënnec, | Recruiting |
lyon, France, 69373 | |
Contact: Gisèle Chvetzoff, Dr | |
Principal Investigator: Gisèle Chvetzoff, Dr | |
Sub-Investigator: Isabelle Ray-Coquard, MD | |
Sub-Investigator: Jean-Yves Blay, MD | |
Unité de Soins Palliatifs | Recruiting |
Saint-Etienne, France, 42055 | |
Principal Investigator: Anne Richard | |
Sub-Investigator: Stéphanie Morisson | |
Sub-Investigator: Pascale Vassal | |
Centre Régional d'Accompagnement et de Soins Palliatifs, | Recruiting |
Bordeaux, France, 33000 | |
Principal Investigator: Benoît Burucoa | |
Sub-Investigator: Bernard Paternostre | |
Unité mobile de soutien et de soins palliatifs, Hôpital Saint-Eloi | Recruiting |
Montpellier, France, 34295 | |
Principal Investigator: Josyane Chevallier | |
Sub-Investigator: Jean-Pierre Benezech, MD | |
EMSP, Hôpitaux du Léman | Enrolling by invitation |
Thonon-les-bains, France, 74203 | |
Unité de Soins palliatif, Centre Oscar Lambret | Recruiting |
Lille, France, 59000 | |
Principal Investigator: Michel Reich | |
Sub-Investigator: Stéphanie Villet | |
Sub-Investigator: Isabelle Rodrigues | |
Sub-Investigator: Caroline Jezzine | |
Sub-Investigator: Vincent Gamblin | |
EMSP, Institut Curie | Enrolling by invitation |
PARIS, France, 75005 | |
EMSP, hôpital Saint aAntoine | Enrolling by invitation |
Paris, France, 75012 | |
Praz-Coutant | Enrolling by invitation |
Passy, France, 74190 | |
Unité de Soins Palliatifs, Hôpital Lyon sud | Recruiting |
Lyon, France, 69000 | |
Principal Investigator: Marilène Filbet | |
Sub-Investigator: Aurélie Laurent |
Principal Investigator: | Guillemette Laval, M.D., Ph.D. | University Hospital, Grenoble |
Responsible Party: | Direction de la recherche clinique et de l'innovation ( Mr Svahn ) |
Study ID Numbers: | DCIC 03 29 |
Study First Received: | January 6, 2006 |
Last Updated: | March 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00273741 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
palliative care methylphenidate |
Signs and Symptoms Dopamine Asthenia Methylphenidate |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Neoplasms Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Physiological Effects of Drugs Central Nervous System Stimulants Dopamine Agents Central Nervous System Agents Pharmacologic Actions |