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

This study has been terminated.
(difficulty of recrutement)
Sponsor:
Collaborators:
Fondation de France
Ligue contre le cancer, France
Information provided by:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00273741
First received: January 6, 2006
Last updated: December 4, 2009
Last verified: December 2009
  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 3

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

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 ]

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Publications:
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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Grenoble:
palliative care
methylphenidate

Additional relevant MeSH terms:
Asthenia
Neoplasms
Signs and Symptoms
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on August 19, 2014