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

NCT ID: NCT00273741

Last Updated: 2009-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2009-06-30

Brief Summary

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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

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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.

Conditions

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Asthenia Neoplasms

Keywords

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palliative care methylphenidate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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

Group Type EXPERIMENTAL

methylphenidate

Intervention Type DRUG

methylphenidate per os 20mg per day 7 days, 20mg or 40mg per day 7 days and 20, 40 or 60mg per day 14 days

2

placebo capsules

Group Type PLACEBO_COMPARATOR

placebo comparator

Intervention Type DRUG

placebo capsules

Interventions

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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

Intervention Type DRUG

placebo comparator

placebo capsules

Intervention Type DRUG

Other Intervention Names

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active placebo

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation de France

OTHER

Sponsor Role collaborator

Ligue contre le cancer, France

OTHER

Sponsor Role collaborator

University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Direction de la recherche clinique et de l'innovation

Principal Investigators

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Guillemette Laval, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

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Hôpital D'Annemasse

Annemasse, , France

Site Status

Centre Régional d'Accompagnement et de Soins Palliatifs,

Bordeaux, , France

Site Status

Equipe mobile de recherche et de soutien en soins pallitaifs

Grenoble, , France

Site Status

Unité de Soins palliatif, Centre Oscar Lambret

Lille, , France

Site Status

Unité de Soins Palliatifs, Hôpital Lyon sud

Lyon, , France

Site Status

Soins Palliatifs et Soins de support, Centre Léon Bérard, 28 rue Laënnec,

Lyon, , France

Site Status

Unité mobile de soutien et de soins palliatifs, Hôpital Saint-Eloi

Montpellier, , France

Site Status

EMSP, Institut Curie

Paris, , France

Site Status

EMSP, hôpital Saint aAntoine

Paris, , France

Site Status

Praz-Coutant

Passy, , France

Site Status

Unité de Soins Palliatifs

Saint-Etienne, , France

Site Status

EMSP, Hôpitaux du Léman

Thonon-les-Bains, , France

Site Status

Institut Gustave Roussy

Villejuif, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 1589233 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7539701 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11773187 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3791269 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14645434 (View on PubMed)

Other Identifiers

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DCIC 03 29

Identifier Type: -

Identifier Source: org_study_id