A Phase 3 interventional study of methylphenidate and placebo comparator in Asthenia and Neoplasms, sponsored by University Hospital, Grenoble. Terminated at 13 sites in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2009-12-07.
Sponsored by University Hospital, Grenoble · Phase 3, Interventional, and Treatment
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.
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.
119 studies on the registry are indexed under Asthenia; 25 are open to participants now.
This study's enrollment of 39 is close to the median of 42 across 84 interventional studies indexed under Asthenia.
Browse Asthenia studies →University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
methylphenidate at 20mg per day during 7 days, at 20mg or 40mg per day during 7 days and 20, 40 or 60mg per day during 14 days
Drug: methylphenidate
placebo capsules
Drug: placebo comparator
methylphenidate per os 20mg per day 7 days, 20mg or 40mg per day 7 days and 20, 40 or 60mg per day 14 days
Also known as: active
placebo capsules
Also known as: placebo
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)
Time frame: 7 days AVS
Adverse events
Time frame: each day
Visual analogical scale of pain
Time frame: inclusion, day 1, 2, 3, 7, 14 and 28
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30
Time frame: day 1, 7 and 28
Multidimensional Fatigue Inventory-20 (MFI-20)
Time frame: day 1, 7, 14 and 28
Hospital Anxiety and Depression Scale (HADS)
Time frame: inclusion, 7 and 28
This study is terminated, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.
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University Hospital, Grenoble