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

Brief Title

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

Official Title

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

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.
    

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 Phase

Phase 3

Study Type

Interventional


Primary Outcome

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)

Secondary Outcome

 Adverse events

Condition

Asthenia

Intervention

methylphenidate

Study Arms / Comparison Groups

 1
Description:  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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

39

Start Date

January 2007

Completion Date

June 2009

Primary Completion Date

June 2009

Eligibility 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
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Guillemette Laval, M.D., Ph.D., , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT00273741

Organization ID

DCIC 03 29



Study Sponsor

University Hospital, Grenoble

Collaborators

 Fondation de France

Study Sponsor

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


Verification Date

December 2009