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

Phase 3

• Conditions: Cancer; Pain

• Registration Number: NCT00181012
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Status Verified: 2006-09
• Last Update Submitted: 2007-09-18
• Last Update Posted: 2007-09-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
To confirm the tolerance of the lidocaine

Trial Locations

Locations (1)

Institut Gustave-Roussy; 🇫🇷 Villejuif, France