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Ritalin: Antiasthenic Effect of Methylphenidate (Ritalin) in Palliative Care in Cancer Patients (Ritaline)
This study is currently recruiting participants.
Verified by University Hospital, Grenoble, February 2009
First Received: January 6, 2006   Last Updated: February 16, 2009   History of Changes
Sponsors and Collaborators: University Hospital, Grenoble
Fondation de France
Ligue nationale Contre le Cancer
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: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: each day ] [ Designated as safety issue: Yes ]
  • Visual analogical scale of pain [ Time Frame: inclusion, day 1, 2, 3, 7, 14 and 28 ] [ Designated as safety issue: No ]
  • European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 [ Time Frame: day 1, 7 and 28 ] [ Designated as safety issue: No ]
  • Multidimensional Fatigue Inventory-20 (MFI-20) [ Time Frame: day 1, 7, 14 and 28 ] [ Designated as safety issue: No ]
  • Hospital Anxiety and Depression Scale (HADS) [ Time Frame: inclusion, 7 and 28 ] [ Designated as safety issue: No ]

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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00273741

Contacts
Contact: Denis Moro-Sibillot, M.D., Ph.D. 04-76-76-92-60

Locations
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            
Sponsors and Collaborators
University Hospital, Grenoble
Fondation de France
Ligue nationale Contre le Cancer
Investigators
Principal Investigator: Guillemette Laval, M.D., Ph.D. University Hospital, Grenoble
  More Information

Publications:
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

Keywords provided by University Hospital, Grenoble:
palliative care
methylphenidate

Study placed in the following topic categories:
Dopamine Uptake Inhibitors
Signs and Symptoms
Neurotransmitter Agents
Dopamine
Asthenia
Methylphenidate
Central Nervous System Stimulants
Dopamine Agents

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 01, 2009