Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00273741
Status:
TERMINATED
Last Update Posted:
2009-12-07
First Post:
2006-01-06
Brief Title:
Ritalin Antiasthenic Effect of Methylphenidate Ritalin in Palliative Care in Cancer Patients
Sponsor:
University Hospital Grenoble
Organization:
University Hospital Grenoble
Study Overview
Official Title:
Randomized Study Evaluating the Antiasthenic Effect of Methylphenidate Ritalin in Palliative Care in Cancer Patients
Status:
TERMINATED
Status Verified Date:
2009-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
difficulty of recrutement
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Ritaline
Brief Summary:
The aimobjective 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 ie with a progressive or terminal disease
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None