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

Grenoble Alpes University Hospital Center (CHU)

Status and phase

Terminated

Phase 3

Conditions

Neoplasms

Asthenia

Treatments

Drug: methylphenidate

Drug: placebo comparator

Study type

Interventional

Funder types

Other

Identifiers

NCT00273741

DCIC 03 29

Details and patient eligibility

About

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.

Full 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.

Enrollment

39 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Advanced phase of neoplasm without any treatment available.
Life expectancy of more than 1 month
Karnofsky index more than 50%
Chemotherapy IV or immunotherapy SC stopped more than 3 weeks before the end of the study
Asthenia more than 5/10 on the visual analogical scale
Informed consent form signed
Affiliation to social security

Exclusion criteria

Patients who can receive chemotherapy IV or immunotherapy SC in the month following the study
Patients in whom disease can respond to chemotherapy
Corticotherapy started less than 7 days before the study or potentially within the first week of the study
Asthenia which can be easily corrected
Contraindications to the amphetamines
HADS score of anxiety and/or depression more than or egal to 17/21
Potential surgery with general anesthesia in the first 7 days of the study
Inability to quantify the sensation of asthenia on the visual analogical scale
Pregnancy or feeding
Guardianship