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

December 4, 2009 updated by: University Hospital, Grenoble

Randomized Study Evaluating the Antiasthenic Effect of Methylphenidate (Ritalin) in Palliative Care in Cancer Patients

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Annemasse, France, 74107
        • Hôpital D'Annemasse
      • Bordeaux, France, 33000
        • Centre Régional d'Accompagnement et de Soins Palliatifs,
      • Grenoble, France, 38043
        • Equipe mobile de recherche et de soutien en soins pallitaifs
      • Lille, France, 59000
        • Unité de Soins palliatif, Centre Oscar Lambret
      • Lyon, France, 69000
        • Unité de Soins Palliatifs, Hôpital Lyon sud
      • Lyon, France, 69373
        • Soins Palliatifs et Soins de support, Centre Léon Bérard, 28 rue Laënnec,
      • Montpellier, France, 34295
        • Unité mobile de soutien et de soins palliatifs, Hôpital Saint-Eloi
      • Paris, France, 75005
        • EMSP, Institut Curie
      • Paris, France, 75012
        • EMSP, hôpital Saint aAntoine
      • Passy, France, 74190
        • Praz-Coutant
      • Saint-Etienne, France, 42055
        • Unité de Soins Palliatifs
      • Thonon-les-bains, France, 74203
        • EMSP, Hôpitaux du Léman
      • Villejuif, France, 94805
        • Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
placebo capsules
Drug: placebo comparator
placebo capsules
Other Names:
  • placebo
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
7 days AVS

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: each day
each day
Visual analogical scale of pain
Time Frame: inclusion, day 1, 2, 3, 7, 14 and 28
inclusion, day 1, 2, 3, 7, 14 and 28
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30
Time Frame: day 1, 7 and 28
day 1, 7 and 28
Multidimensional Fatigue Inventory-20 (MFI-20)
Time Frame: day 1, 7, 14 and 28
day 1, 7, 14 and 28
Hospital Anxiety and Depression Scale (HADS)
Time Frame: inclusion, 7 and 28
inclusion, 7 and 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

Ligue contre le cancer, France
Fondation de France

Investigators

  • Principal Investigator: Guillemette Laval, M.D., Ph.D., University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

January 6, 2006

First Submitted That Met QC Criteria

January 6, 2006

First Posted (Estimate)

January 9, 2006

Study Record Updates

Last Update Posted (Estimate)

December 7, 2009

Last Update Submitted That Met QC Criteria

December 4, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCIC 03 29

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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