Clincosm LogoSign in Get a demo

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

Sponsor
University Hospital, Grenoble (Other)
Overall Status
Terminated
CT.gov ID
NCT00273741
Collaborator
Fondation de France (Other), Ligue contre le cancer, France (Other)
39
Enrollment
13
Locations
2
Arms
29
Duration (Months)
3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
39 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Randomized Study Evaluating the Antiasthenic Effect of Methylphenidate (Ritalin) in Palliative Care in Cancer Patients
Study Start Date :
Jan 1, 2007
Actual Primary Completion Date :
Jun 1, 2009
Actual Study Completion Date :
Jun 1, 2009

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • active

    		•
    Placebo Comparator: 2

    placebo capsules

    Drug: placebo comparator
    placebo capsules
    Other Names:
  • placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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) [7 days AVS]

    Secondary Outcome Measures

    1. Adverse events [each day]

    2. Visual analogical scale of pain [inclusion, day 1, 2, 3, 7, 14 and 28]

    3. European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 [day 1, 7 and 28]

    4. Multidimensional Fatigue Inventory-20 (MFI-20) [day 1, 7, 14 and 28]

    5. Hospital Anxiety and Depression Scale (HADS) [inclusion, 7 and 28]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Hôpital D'Annemasse Annemasse France 74107
    2 Centre Régional d'Accompagnement et de Soins Palliatifs, Bordeaux France 33000
    3 Equipe mobile de recherche et de soutien en soins pallitaifs Grenoble France 38043
    4 Unité de Soins palliatif, Centre Oscar Lambret Lille France 59000
    5 Unité de Soins Palliatifs, Hôpital Lyon sud Lyon France 69000
    6 Soins Palliatifs et Soins de support, Centre Léon Bérard, 28 rue Laënnec, Lyon France 69373
    7 Unité mobile de soutien et de soins palliatifs, Hôpital Saint-Eloi Montpellier France 34295
    8 EMSP, Institut Curie Paris France 75005
    9 EMSP, hôpital Saint aAntoine Paris France 75012
    10 Praz-Coutant Passy France 74190
    11 Unité de Soins Palliatifs Saint-Etienne France 42055
    12 EMSP, Hôpitaux du Léman Thonon-les-bains France 74203
    13 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00273741
    Other Study ID Numbers:
    • DCIC 03 29
    First Posted:
    Jan 9, 2006
    Last Update Posted:
    Dec 7, 2009
    Last Verified:
    Dec 1, 2009
    Keywords provided by , ,
    palliative care
    methylphenidate
    Additional relevant MeSH terms:
    Asthenia
    Methylphenidate

    Study Results

    No Results Posted as of Dec 7, 2009