NCT00181012

Brief Summary

This study will evaluate the benefit of lidocaine perfusion in cancer related visceral pain resistant to morphinics. It is an efficacy study in adults and children and a randomized prospective study.

Trial Health

55
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Trial Health Score

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

Enrollment
100

participants targeted

Target at P25-P50 for phase_3 cancer

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

September 19, 2007

Status Verified

September 1, 2006

First QC Date

September 13, 2005

Last Update Submit

September 18, 2007

Conditions

CancerPain

Keywords

Cancer Related Visceral Pain Resistant to Morphinics

Outcome Measures

Primary Outcomes (1)

  • To determine prospectively the lidocaine efficacy in 2 types of patient populations with cancer (group A: children from 6 to 14 years old and group B: adults from 15 to 70 years old)

    continuous intravenous perfusion for 6 days

Secondary Outcomes (1)

  • To confirm the tolerance of the lidocaine

Interventions

LidocaineDRUG

Eligibility Criteria

Age6 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients suffering from cancer of any type, at any stage, hospitalized at the Institut Gustave Roussy
  • Aged from 6 to 14 years old (group A) and from 15 to 70 years old (adults)
  • Presenting visceral pain due to neurotoxic chemotherapy, due to the tumoral mass or to peritoneal carcinosis
  • Pain resistant to morphinic treatment

You may not qualify if:

  • Cardiac troubles, clinical cardiac insufficiency, or history of myocardial infarction (MI) of less than 3 months
  • Neurological: non-controlled epilepsy, encephalopathy, or dementia
  • Severe hepatic insufficiency
  • Severe renal insufficiency
  • Respiratory insufficiency
  • Patients having surgery or in postoperative period
  • Known deficit in G6PD, alanine exposure, or sulphamide treatment
  • Porphyria
  • Weight \> 80 kg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Gustave-Roussy

Villejuif, 94800, France

RECRUITING

MeSH Terms

Conditions

NeoplasmsPain

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Philippe Poulain, MD

    Gustave Roussy, Cancer Campus, Grand Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe Poulain, MD

CONTACT

33 1 42 11 40 53poulain@igr.fr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

May 1, 2005

Last Updated

September 19, 2007

Record last verified: 2006-09

Locations

FR(1)