Unité de recherche et de soutien en soins palliatifs, CHU, BP 217, 38043 Grenoble Cedex 09, Centre d’investigation clinique, hôpital Michallon, BP 217, 38043 Grenoble Cedex 09
The amphetamine, methylphenidate (Ritaline
®) has been proposed as being of interest in the treatment of asthenia in patients with advanced cancer. To evaluate this hypothesis a randomised controlled double-blind parallel-group national multi-centre trial is proposed versus placebo. Three previous randomised controlled studies and one open study have suggested that the administration of methylphenidate may be of interest in the palliative care of asthenic cancer patients. However, these studies do not permit a definitive conclusion to be drawn. This article presents the protocol of our new trial. The primary objective is to evaluate the anti-asthenic effect of methylphenidate using a visual analogue scale (VAS) after 7 days of treatment of cancer patients in palliative care, i.e. when the cancer is considered to be rapidly evolving or as terminal. One hundred and ten patients are treated for 28 days at a starting dose of 20 mg/day, and adjustment of the dose is possible. It is important to stress that only the concerted efforts of an interdisciplinary team (somatologues, psychiatrists, psychologists, paramedical carers and social workers) can tackle the challenges posed by the difficult symptom of asthenia. The medical treatment is only one element of the approach to caring for these patients.