Status:
TERMINATED
Ritalin: Antiasthenic Effect of Methylphenidate (Ritalin) in Palliative Care in Cancer Patients
Lead Sponsor:
University Hospital, Grenoble
Collaborating Sponsors:
Fondation de France
Ligue contre le cancer, France
Conditions:
Asthenia
Neoplasms
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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. w...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00273741
Start Date
January 1 2007
End Date
June 1 2009
Last Update
December 7 2009
Active Locations (13)
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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