The aim objective of this study is to evaluate the antiasthenic effect of methylphenidate with visual analogical scale (VAS) after 7 days of treatment, in cancer patients, in palliative care, i.e. with progressive or terminal disease.

Condition	Intervention	Phase
Palliative Care Asthenia Neoplasms Methylphenidate	Drug: Methylphenidate	Phase III

Further study details as provided by University Hospital of Grenoble:

Primary Outcomes: 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 an analogic visual scale at day7 (+/- 1 day).
Secondary Outcomes: adverse events;; visual analogic scale of pain;; EORTC QLQ-C30;; MFI20;; HADS
Expected Total Enrollment:  70

Cancer patients in advanced phase or terminally ill generally presents 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 advanced phase of the disease presents an important asthenia. In some patients, this asthenia is characterized by drowsiness or apathy. It always leads to ill-being and 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 fight. But, when it appears in patient not really in end of life (life expectancy more than 1 month) and when no etiologic treatment are possible, others solutions must be considered, and all the more that the complaint is important with repeated request of relief.

The methylphenidate is an amphetamine firstly indicated in deficient attention disorders with hyperactivity in children more than 6 years. Several studies have been realized to evaluate its effect in cancer patients in palliative care. Some studies showed, in particular, that its effectiveness on asthenia because of a stimulant and an antidepressant action. The methylphenidate could have an anti-analgesic effect or co-analgesic. All these studies are observational and not randomized. So they have a little 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 need to be experimented.

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• advanced phase of neoplasm without any treatment available.
• life expectancy more than 1 month
• Karnofsky index more than 50%
• chemotherapy or immunotherapy stopped more than 3 weeks before the end of the study
• asthenia more than 5/10 on the visual analogic scale
• informed consent form signed
• affiliation to the social security

Exclusion Criteria:

• patient who can receive chemotherapy or immunotherapy in the month following the study
• patient whom disease can response to the chemotherapy
• chemotherapy started less than 7 days before the study or potentially in the first week of the study
• asthenia which can be easily corrected
• contre indications to the amphetamines
• potential surgery with general anesthesia in the 7 first days of the study
• unability to quantify the sensation of asthenia on the visual analogic scale
• pregnancy or feeding
• guardianship

Please refer to this study by ClinicalTrials.gov identifier  NCT00273741

Denis Moro-Sibillot, M.D., Ph.D.      04-76-76-92-60 

France
      Equipe mobile de recherche et de soutien en soins pallitaifs, Grenoble,  38043,  France

Study chairs or principal investigators

Guillemette LAVAL, M.D., Ph.D.,  Principal Investigator,  University Hospital of Grenoble   

Study ID Numbers:  DCIC-03-29
Last Updated:  January 6, 2006
Record first received:  January 6, 2006
ClinicalTrials.gov Identifier:  NCT00273741
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2006-01-10