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

Condition(s) targeted: Asthenia; Neoplasms

Intervention: methylphenidate (Drug); placebo comparator (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: University Hospital, Grenoble

Official(s) and/or principal investigator(s):
Guillemette Laval, M.D., Ph.D., Principal Investigator, Affiliation: University Hospital, Grenoble

Overall contact:
Denis Moro-Sibillot, M.D., Ph.D., Phone: 04-76-76-92-60

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.

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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

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)

Secondary outcome:

Adverse events

Visual analogical scale of pain

European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30

Multidimensional Fatigue Inventory-20 (MFI-20)

Hospital Anxiety and Depression Scale (HADS)

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.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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

Denis Moro-Sibillot, M.D., Ph.D., Phone: 04-76-76-92-60

Equipe mobile de recherche et de soutien en soins pallitaifs, GRENOBLE 38043, France; Recruiting
Guillemette Laval, M.D., Ph.D.
Marie-Laure Villard, Sub-Investigator
Guillemette Laval, Dr, Principal Investigator
Nicolas BEZIAUD, Dr, Sub-Investigator
Virginie Noël, Dr, Sub-Investigator

Soins Palliatifs et Soins de support, Centre Léon Bérard, 28 rue Laënnec,, lyon 69373, France; Recruiting
Gisèle Chvetzoff, Dr
Gisèle Chvetzoff, Dr, Principal Investigator
Isabelle Ray-Coquard, MD, Sub-Investigator
Jean-Yves Blay, MD, Sub-Investigator

Unité de Soins Palliatifs, Saint-Etienne 42055, France; Recruiting
Anne Richard, Principal Investigator
Stéphanie Morisson, Sub-Investigator
Pascale Vassal, Sub-Investigator

Centre Régional d'Accompagnement et de Soins Palliatifs,, Bordeaux 33000, France; Recruiting
Benoît Burucoa, Principal Investigator
Bernard Paternostre, Sub-Investigator

Unité mobile de soutien et de soins palliatifs, Hôpital Saint-Eloi, Montpellier 34295, France; Recruiting
Josyane Chevallier, Principal Investigator
Jean-Pierre Benezech, MD, Sub-Investigator

Unité de Soins Palliatifs, Hôpital Lyon sud, Lyon 69000, France; Recruiting
Marilène Filbet, Principal Investigator
Aurélie Laurent, Sub-Investigator

Unité de Soins palliatif, Centre Oscar Lambret, Lille 59000, France; Recruiting
Michel Reich, Principal Investigator
Stéphanie Villet, Sub-Investigator
Isabelle Rodrigues, Sub-Investigator
Caroline Jezzine, Sub-Investigator
Vincent Gamblin, Sub-Investigator

EMSP, Institut Curie, PARIS 75005, France; Recruiting
Laure Copel, MD, Principal Investigator
Geneviève Gridel, Dr, Sub-Investigator

EMSP, hôpital Saint aAntoine, Paris 75012, France; Recruiting
Sylvie Rostaing, MD, Principal Investigator
Christian Guy-Coichard, MD, Sub-Investigator

Praz-Coutant, Passy 74190, France; Recruiting
Michel Moriceau, MD, Principal Investigator

EMSP, Hôpitaux du Léman, Thonon-les-bains 74203, France; Recruiting
Vincent Indirli, MD, Principal Investigator
Véronique Li, Dr, Sub-Investigator
Jacques Salvat, dr, Sub-Investigator
Philippe Romand, Dr, Sub-Investigator
Anne-Sophie bugnet, Dr, Sub-Investigator
Bernadette Isoard, Dr, Sub-Investigator
Ahmed bedjaoui, Dr, Sub-Investigator

Institut Gustave Roussy, Villejuif 94805, France; Recruiting
Sarah Dauchy, Dr
Sabine Voisin-Saltiel, Dr
Pascal Rouby, Sub-Investigator
Sabine Voisin-Saltiel, Dr, Sub-Investigator
Sarah dauchy, Dr, Principal Investigator

Hôpital D'Annemasse, Annemasse 74107, France; Recruiting
Laurence alcover, Dr, Principal Investigator
Patrick Chatellain, Dr, Sub-Investigator

Related publications:

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.

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.

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.

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.

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.

Starting date: January 2007
Ending date: December 2010
Last updated: February 16, 2009