Benefit of Lidocaine Perfusion in Cancer Related Visceral Pain Resistant to Morphinics

September 18, 2007 updated by: Gustave Roussy, Cancer Campus, Grand Paris

Benefit of Lidocaine Perfusion in Cancer Related Visceral Pain Resistant to Morphinics: Efficacy Study in Adults and Children. Randomized Prospective Study With Direct Individual Benefit

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Philippe Poulain, MD
  • Phone Number: 33 1 42 11 40 53
  • Email: poulain@igr.fr

Study Locations

  • France
      • Villejuif, France, 94800
        • Recruiting
        • Institut Gustave-Roussy
        • Contact:
          • Philippe Poulain, MD
          • Phone Number: 33 1 42 11 40 53
          • Email: poulain@igr.fr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Time Frame: continuous intravenous perfusion for 6 days
continuous intravenous perfusion for 6 days

Secondary Outcome Measures

Outcome Measure
To confirm the tolerance of the lidocaine

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Investigators

  • Principal Investigator: Philippe Poulain, MD, Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

September 19, 2007

Last Update Submitted That Met QC Criteria

September 18, 2007

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LIDODOULABDO
  • CSET 2003/1054

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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