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| Sponsor: | University Hospital, Grenoble |
|---|---|
| Collaborators: |
Fondation de France Ligue contre le cancer, France |
| Information provided by: | University Hospital, Grenoble |
| ClinicalTrials.gov Identifier: | NCT00273741 |
Purpose
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 |
|---|---|---|
|
Asthenia Neoplasms |
Drug: methylphenidate Drug: placebo comparator |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Randomized Study Evaluating the Antiasthenic Effect of Methylphenidate (Ritalin) in Palliative Care in Cancer Patients |
| Enrollment: | 39 |
| Study Start Date: | January 2007 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| France | |
| 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 | |
| Praz-Coutant | |
| 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 | |
| Principal Investigator: | Guillemette Laval, M.D., Ph.D. | University Hospital, Grenoble |
More Information
| Responsible Party: | Mr Marie, Direction de la recherche clinique et de l'innovation |
| ClinicalTrials.gov Identifier: | NCT00273741 History of Changes |
| Other Study ID Numbers: | DCIC 03 29 |
| Study First Received: | January 6, 2006 |
| Last Updated: | December 4, 2009 |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
|
palliative care methylphenidate |
|
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 |