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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Randomized Study Evaluating the Antiasthenic Effect of Methylphenidate (Ritalin) in Palliative Care in Cancer Patients

Brief 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.

Detailed Summary:

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.


Sponsor: University Hospital, Grenoble

Current Primary Outcome: 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 ]

Original Primary Outcome: 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).

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • adverse events;
  • visual analogic scale of pain;
  • EORTC QLQ-C30;
  • MFI20;
  • HADS


Information By: University Hospital, Grenoble

Dates:
Date Received: January 6, 2006
Date Started: January 2007
Date Completion:
Last Updated: December 4, 2009
Last Verified: December 2009