Clinical trial NCT00273741: Ritalin: Antiasthenic Effect of Methylphenidate (Ritalin) in Palliative Care in Cancer Patients
Official title: Randomized Study Evaluating the Antiasthenic Effect of Methylphenidate (Ritalin) in Palliative Care in Cancer Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Asthenia
Neoplasms
Keywords: palliative care
methylphenidate
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Fondation de France
name: Ligue contre le cancer, France
First posted: 2006-01-09
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: 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)
timeFrame: 7 days AVS
Secondary outcomes:
measure: Adverse events
timeFrame: each day
measure: Visual analogical scale of pain
timeFrame: inclusion, day 1, 2, 3, 7, 14 and 28
measure: European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30
timeFrame: day 1, 7 and 28
measure: Multidimensional Fatigue Inventory-20 (MFI-20)
timeFrame: day 1, 7, 14 and 28
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: inclusion, 7 and 28
Other outcomes:
Locations:
city: Annemasse
country: France
facility: Hôpital D'Annemasse
city: Bordeaux
country: France
facility: Centre Régional d'Accompagnement et de Soins Palliatifs,
city: Grenoble
country: France
facility: Equipe mobile de recherche et de soutien en soins pallitaifs
city: Lille
country: France
facility: Unité de Soins palliatif, Centre Oscar Lambret
city: Lyon
country: France
facility: Unité de Soins Palliatifs, Hôpital Lyon sud
city: Lyon
country: France
facility: Soins Palliatifs et Soins de support, Centre Léon Bérard, 28 rue Laënnec,
city: Montpellier
country: France
facility: Unité mobile de soutien et de soins palliatifs, Hôpital Saint-Eloi
city: Paris
country: France
facility: EMSP, Institut Curie
city: Paris
country: France
facility: EMSP, hôpital Saint aAntoine
city: Passy
country: France
facility: Praz-Coutant
city: Saint-Etienne
country: France
facility: Unité de Soins Palliatifs
city: Thonon-les-bains
country: France
facility: EMSP, Hôpitaux du Léman
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: University Hospital, Grenoble
name: Guillemette Laval, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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):163-166. doi: 10.1016/0304-3959(92)90053-E.
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. doi: 10.1007/BF00365854.
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. doi: 10.1200/JCO.2002.20.1.335.
citation: 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.
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. doi: 10.1200/JCO.2003.06.156.