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

• Status: Terminated
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Grenoble
• Collaborators: Fondation de France; Ligue contre le cancer, France
• Treatments: Methylphenidate

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