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

Phase 3

Terminated

• Conditions: Asthenia; Neoplasms
• Interventions: Drug: placebo comparator; Drug: methylphenidate

• Registration Number: NCT00273741
• Lead Sponsor: University Hospital, Grenoble

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 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.

Study Timeline

• Study First Submitted: 2006-01-06
• Study First Submitted QC: 2006-01-06
• Study First Posted: 2006-01-09
• Study Start: 2007-01
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-04
• Last Update Posted: 2009-12-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	placebo comparator	placebo capsules
1	methylphenidate	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

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Multidimensional Fatigue Inventory-20 (MFI-20)	day 1, 7, 14 and 28
Hospital Anxiety and Depression Scale (HADS)	inclusion, 7 and 28
Adverse events	each day
Visual analogical scale of pain	inclusion, day 1, 2, 3, 7, 14 and 28
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30	day 1, 7 and 28

Trial Locations

Locations (13)

Unité de Soins Palliatifs; 🇫🇷 Saint-Etienne, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France

EMSP, Hôpitaux du Léman; 🇫🇷 Thonon-les-bains, France

Soins Palliatifs et Soins de support, Centre Léon Bérard, 28 rue Laënnec,; 🇫🇷 Lyon, France

Hôpital D'Annemasse; 🇫🇷 Annemasse, France

Unité de Soins palliatif, Centre Oscar Lambret; 🇫🇷 Lille, France

Unité de Soins Palliatifs, Hôpital Lyon sud; 🇫🇷 Lyon, France

Centre Régional d'Accompagnement et de Soins Palliatifs,; 🇫🇷 Bordeaux, France

Equipe mobile de recherche et de soutien en soins pallitaifs; 🇫🇷 Grenoble, France

Unité mobile de soutien et de soins palliatifs, Hôpital Saint-Eloi; 🇫🇷 Montpellier, France

Praz-Coutant; 🇫🇷 Passy, France

EMSP, Institut Curie; 🇫🇷 Paris, France

EMSP, hôpital Saint aAntoine; 🇫🇷 Paris, France