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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier:
NCT00181012
First received: September 13, 2005
Last updated: September 18, 2007
Last verified: September 2006
  Purpose

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.


Condition Intervention Phase
Cancer
Pain
Drug: Lidocaine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • To confirm the tolerance of the lidocaine

Estimated Enrollment: 100
Study Start Date: May 2005
  Eligibility

Ages Eligible for Study:   6 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00181012

Contacts
Contact: Philippe Poulain, MD 33 1 42 11 40 53 poulain@igr.fr

Locations
France
Institut Gustave-Roussy Recruiting
Villejuif, France, 94800
Contact: Philippe Poulain, MD    33 1 42 11 40 53    poulain@igr.fr   
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Investigators
Principal Investigator: Philippe Poulain, MD Gustave Roussy, Cancer Campus, Grand Paris
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00181012     History of Changes
Other Study ID Numbers: LIDODOULABDO, CSET 2003/1054
Study First Received: September 13, 2005
Last Updated: September 18, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Gustave Roussy, Cancer Campus, Grand Paris:
Cancer Related Visceral Pain Resistant to Morphinics

Additional relevant MeSH terms:
Visceral Pain
Nervous System Diseases
Neurologic Manifestations
Nociceptive Pain
Pain
Signs and Symptoms
Lidocaine
Anesthetics
Anesthetics, Local
Anti-Arrhythmia Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on October 22, 2014