Randomized Study Evaluating the Antiasthenic Effect of Methylphenidate (Ritalin) in Palliative Care in Cancer Patients
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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)
7 days AVS
Guillemette Laval, M.D., Ph.D.
University Hospital, Grenoble
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
DCIC 03 29