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

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Primary Purpose

Status

Unknown status

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

Lidocaine

About this trial

This is an interventional treatment trial for Cancer focused on measuring Cancer Related Visceral Pain Resistant to Morphinics

Eligibility Criteria

6 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Institut Gustave-RoussyRecruiting

Outcomes

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)

Secondary Outcome Measures

To confirm the tolerance of the lidocaine

Full Information

NCT ID

NCT00181012

First Posted

September 13, 2005

Last Updated

September 18, 2007

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

1. Study Identification

Unique Protocol Identification Number

NCT00181012

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2006

Overall Recruitment Status

Unknown status

Study Start Date

May 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer, Pain

Keywords

Cancer Related Visceral Pain Resistant to Morphinics

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Lidocaine

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

To confirm the tolerance of the lidocaine

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

No

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Philippe Poulain, MD

Phone

33 1 42 11 40 53

Email

poulain@igr.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Philippe Poulain, MD

Organizational Affiliation

Gustave Roussy, Cancer Campus, Grand Paris

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institut Gustave-Roussy

City

Villejuif

ZIP/Postal Code

94800

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Philippe Poulain, MD

Phone

33 1 42 11 40 53

Email

poulain@igr.fr

Cancer, Pain

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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