Ritalin: Antiasthenic Effect of Methylphenidate (Ritalin) in Palliative Care in Cancer Patients (Ritaline)
Randomized Study Evaluating the Antiasthenic Effect of Methylphenidate (Ritalin) in Palliative Care in Cancer Patients
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
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Annemasse, France, 74107
- Hôpital D'Annemasse
-
Bordeaux, France, 33000
- Centre Régional d'Accompagnement et de Soins Palliatifs,
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Grenoble, France, 38043
- Equipe mobile de recherche et de soutien en soins pallitaifs
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Lille, France, 59000
- Unité de Soins palliatif, Centre Oscar Lambret
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Lyon, France, 69000
- Unité de Soins Palliatifs, Hôpital Lyon sud
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Lyon, France, 69373
- Soins Palliatifs et Soins de support, Centre Léon Bérard, 28 rue Laënnec,
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Montpellier, France, 34295
- Unité mobile de soutien et de soins palliatifs, Hôpital Saint-Eloi
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Paris, France, 75005
- EMSP, Institut Curie
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Paris, France, 75012
- EMSP, hôpital Saint aAntoine
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Passy, France, 74190
- Praz-Coutant
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Saint-Etienne, France, 42055
- Unité de Soins Palliatifs
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Thonon-les-bains, France, 74203
- EMSP, Hôpitaux du Léman
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Villejuif, France, 94805
- Institut Gustave Roussy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: 2
placebo capsules
|
placebo capsules
Other Names:
|
|
Experimental: 1
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
|
methylphenidate per os 20mg per day 7 days, 20mg or 40mg per day 7 days and 20, 40 or 60mg per day 14 days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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)
Time Frame: 7 days AVS
|
7 days AVS
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Adverse events
Time Frame: each day
|
each day
|
|
Visual analogical scale of pain
Time Frame: inclusion, day 1, 2, 3, 7, 14 and 28
|
inclusion, day 1, 2, 3, 7, 14 and 28
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30
Time Frame: day 1, 7 and 28
|
day 1, 7 and 28
|
|
Multidimensional Fatigue Inventory-20 (MFI-20)
Time Frame: day 1, 7, 14 and 28
|
day 1, 7, 14 and 28
|
|
Hospital Anxiety and Depression Scale (HADS)
Time Frame: inclusion, 7 and 28
|
inclusion, 7 and 28
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Guillemette Laval, M.D., Ph.D., University Hospital, Grenoble
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DCIC 03 29
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