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

Neoplasms Clinical Trial

— Ritaline  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00273741
• Other study ID #: DCIC 03 29
• Status: Terminated
• Phase: Phase 3
• First received: January 6, 2006
• Last updated: December 4, 2009
• Start date: January 2007
• Est. completion date: June 2009

Study information

• Verified date: December 2009
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthenia
• Neoplasms

Intervention

Drug:
• methylphenidate
methylphenidate per os 20mg per day 7 days, 20mg or 40mg per day 7 days and 20, 40 or 60mg per day 14 days
• placebo comparator
placebo capsules

Locations

Country	Name	City	State
France	Hôpital D'Annemasse	Annemasse
France	Centre Régional d'Accompagnement et de Soins Palliatifs,	Bordeaux
France	Equipe mobile de recherche et de soutien en soins pallitaifs	Grenoble
France	Unité de Soins palliatif, Centre Oscar Lambret	Lille
France	Soins Palliatifs et Soins de support, Centre Léon Bérard, 28 rue Laënnec,	Lyon
France	Unité de Soins Palliatifs, Hôpital Lyon sud	Lyon
France	Unité mobile de soutien et de soins palliatifs, Hôpital Saint-Eloi	Montpellier
France	EMSP, hôpital Saint aAntoine	Paris
France	EMSP, Institut Curie	Paris
France	Praz-Coutant	Passy
France	Unité de Soins Palliatifs	Saint-Etienne
France	EMSP, Hôpitaux du Léman	Thonon-les-bains
France	Institut Gustave Roussy	Villejuif

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Fondation de France, Ligue contre le cancer, France

Country where clinical trial is conducted

France, 

References & Publications (5)

Bruera E, Chadwick S, Brenneis C, Hanson J, MacDonald RN. Methylphenidate associated with narcotics for the treatment of cancer pain. Cancer Treat Rep. 1987 Jan;71(1):67-70. — View Citation

Bruera E, Driver L, Barnes EA, Willey J, Shen L, Palmer JL, Escalante C. Patient-controlled methylphenidate for the management of fatigue in patients with advanced cancer: a preliminary report. J Clin Oncol. 2003 Dec 1;21(23):4439-43. — View Citation

Bruera E, Miller MJ, Macmillan K, Kuehn N. Neuropsychological effects of methylphenidate in patients receiving a continuous infusion of narcotics for cancer pain. Pain. 1992 Feb;48(2):163-6. — View Citation

Rozans M, Dreisbach A, Lertora JJ, Kahn MJ. Palliative uses of methylphenidate in patients with cancer: a review. J Clin Oncol. 2002 Jan 1;20(1):335-9. Review. — View Citation

Wilwerding MB, Loprinzi CL, Mailliard JA, O'Fallon JR, Miser AW, van Haelst C, Barton DL, Foley JF, Athmann LM. A randomized, crossover evaluation of methylphenidate in cancer patients receiving strong narcotics. Support Care Cancer. 1995 Mar;3(2):135-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Adverse events		each day	Yes
Secondary	Visual analogical scale of pain		inclusion, day 1, 2, 3, 7, 14 and 28	No
Secondary	European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30		day 1, 7 and 28	No
Secondary	Multidimensional Fatigue Inventory-20 (MFI-20)		day 1, 7, 14 and 28	No
Secondary	Hospital Anxiety and Depression Scale (HADS)		inclusion, 7 and 28	No