NCT00273741

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

13 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 9, 2006

Completed
12 months until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

December 7, 2009

Status Verified

December 1, 2009

Enrollment Period

2.4 years

First QC Date

January 6, 2006

Last Update Submit

December 4, 2009

Conditions

AstheniaNeoplasms

Keywords

palliative caremethylphenidate

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • Adverse events

    each day

  • Visual analogical scale of pain

    inclusion, day 1, 2, 3, 7, 14 and 28

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

    day 1, 7 and 28

  • Multidimensional Fatigue Inventory-20 (MFI-20)

    day 1, 7, 14 and 28

  • Hospital Anxiety and Depression Scale (HADS)

    inclusion, 7 and 28

Study Arms (2)

1

EXPERIMENTAL

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

Drug: methylphenidate

2

PLACEBO COMPARATOR

placebo capsules

Drug: placebo comparator

Interventions

methylphenidateDRUG

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

Also known as: active
1
placebo comparatorDRUG

placebo capsules

Also known as: placebo
2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Hôpital D'Annemasse

Annemasse, 74107, France

Location

Centre Régional d'Accompagnement et de Soins Palliatifs,

Bordeaux, 33000, France

Location

Equipe mobile de recherche et de soutien en soins pallitaifs

Grenoble, 38043, France

Location

Unité de Soins palliatif, Centre Oscar Lambret

Lille, 59000, France

Location

Unité de Soins Palliatifs, Hôpital Lyon sud

Lyon, 69000, France

Location

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

Lyon, 69373, France

Location

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

Montpellier, 34295, France

Location

EMSP, Institut Curie

Paris, 75005, France

Location

EMSP, hôpital Saint aAntoine

Paris, 75012, France

Location

Praz-Coutant

Passy, 74190, France

Location

Unité de Soins Palliatifs

Saint-Etienne, 42055, France

Location

EMSP, Hôpitaux du Léman

Thonon-les-Bains, 74203, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Related Publications (5)

  • 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.

    PMID: 1589233BACKGROUND

  • 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.

    PMID: 7539701BACKGROUND

  • 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.

    PMID: 11773187BACKGROUND

  • 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.

    PMID: 3791269BACKGROUND

  • 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.

    PMID: 14645434BACKGROUND

MeSH Terms

Conditions

AstheniaNeoplasms

Interventions

MethylphenidateExercise

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Guillemette Laval, M.D., Ph.D.

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 6, 2006

First Posted

January 9, 2006

Study Start

January 1, 2007

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

December 7, 2009

Record last verified: 2009-12

Locations

FR(13)