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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 | |
Unité de Soins Palliatifs, Hôpital Lyon sud | Recruiting |
Lyon, France, 69000 | |
Principal Investigator: Marilène Filbet | |
Sub-Investigator: Aurélie Laurent | |
Hôpital D'Annemasse | Recruiting |
Annemasse, France, 74107 | |
Principal Investigator: Laurence alcover, Dr | |
Sub-Investigator: Patrick Chatellain, Dr | |
EMSP, Institut Curie | Recruiting |
PARIS, France, 75005 | |
Principal Investigator: Laure Copel, MD | |
Sub-Investigator: Geneviève Gridel, Dr | |
EMSP, hôpital Saint aAntoine | Recruiting |
Paris, France, 75012 | |
Principal Investigator: Sylvie Rostaing, MD | |
Sub-Investigator: Christian Guy-Coichard, MD | |
Praz-Coutant | Recruiting |
Passy, France, 74190 | |
Principal Investigator: Michel Moriceau, MD | |
EMSP, Hôpitaux du Léman | Recruiting |
Thonon-les-bains, France, 74203 | |
Principal Investigator: Vincent Indirli, MD | |
Sub-Investigator: Véronique Li, Dr | |
Sub-Investigator: Jacques Salvat, dr | |
Sub-Investigator: Philippe Romand, Dr | |
Sub-Investigator: Anne-Sophie bugnet, Dr | |
Sub-Investigator: Bernadette Isoard, Dr | |
Sub-Investigator: Ahmed bedjaoui, Dr | |
Institut Gustave Roussy | Recruiting |
Villejuif, France, 94805 | |
Contact: Sarah Dauchy, Dr | |
Contact: Sabine Voisin-Saltiel, Dr | |
Sub-Investigator: Pascal Rouby | |
Sub-Investigator: Sabine Voisin-Saltiel, Dr | |
Principal Investigator: Sarah dauchy, Dr | |
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 |
Principal Investigator: | Guillemette Laval, M.D., Ph.D. | University Hospital, Grenoble |
Responsible Party: | Direction de la recherche clinique et de l'innovation ( Mr Marie ) |
Study ID Numbers: | DCIC 03 29 |
Study First Received: | January 6, 2006 |
Last Updated: | February 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00273741 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
palliative care methylphenidate |
Dopamine Uptake Inhibitors Signs and Symptoms Neurotransmitter Agents Dopamine |
Asthenia Methylphenidate Central Nervous System Stimulants Dopamine Agents |
Dopamine Uptake Inhibitors Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Molecular Mechanisms of Pharmacological Action Asthenia Physiological Effects of Drugs Methylphenidate |
Central Nervous System Stimulants Pharmacologic Actions Signs and Symptoms Neoplasms Therapeutic Uses Dopamine Agents Central Nervous System Agents |