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Efficacy of Lidocaine Versus Placebo in Palliative Care Patients With Opioid-refractory Cancer Pain With Neuropathic Component: a Multicenter, Prospective, Double-blind Randomized Placebo-controlled Study. (LIDOSP)

Primary Purpose

Cancer, Pain With Neuropathic Component

Status

Unknown status

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

Lidocaine

Placebo

About this trial

This is an interventional treatment trial for Cancer focused on measuring cancer, pain

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient aged 18 years or older
Patient suffering from cancer pain refractory to standard opiates (numeric pain intensity scale NPIS >=4/10 after 24 hours of continuous intravenous morphine or oxycodone administration [SOR 2002, analgesics drugs for adults cancer nociceptive pain]), regardless of the nature of the primary cancer]
Patient suffering from cancer neuropathic or mixed pain (DNA survey score> = 4 [Bouhassira 2004])
Patient receiving palliative care as defined by French Society of Palliative and Support Care [Charte des Soins Palliatifs, 1996, Act No. 99-477 of 9 June 1999 to guarantee the right of access to palliative care] according to the definition of the World Health Organization (WHO) [World Health Organization. WHO's pain ladder. http://www.who.int/cancer/palliative/painladder/en/. Accessed December 9.2011]
Patient with histological diagnosis of cancer, locally advanced or metastatic disease
Patient without curative cancer treatment, and with or without palliative anticancer treatment
Patient hospitalized in a specific palliative care unit
Patient with an estimated survival higher than 48 hours (physician estimation) Patient providing written informed consent for participation prior to any study procedures.

Exclusion Criteria:

Patient with a known hypersensitivity to lidocaine
Patient with a history of porphyria, arrhythmias, disorders of atrioventricular conduction requiring permanent pacing not yet realized, uncontrolled epilepsy, uncontrolled hypertension
Patient with hematologic malignancy, abnormal renal, hepatic and cardiac functions
Patient with a altered sleepiness (Epworth scale score ≤ 16)
Patient with altered cognitive function (TELECOM scale score> 11) [Arsène 2000]
Patient not native French speaker Patient defined as vulnerable subject (minor subject, pregnant or nursing woman, subject freedom deprived)

Sites / Locations

- Service d'Oncologie Médicale et de Soins Palliatifs Assistance Publique Hopitaux de MarseilleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

lidocaine

placebo

Arm Description

Lidocaine. Initial dose IV will be 5 mg/kg per day during the first 24 hours the 8 mg/kg per day

Outcomes

Primary Outcome Measures

Analgesic efficacy

Analgesic efficacy will be assessed from several endpoints. The primary endpoint will be defined as the change of pain level between baseline (T0) and 40 minutes (T1) after baseline. The pain level will be assessed using a self-administered numeric pain intensity scale (NPIS), ranged from 0 (no pain) to 10 (worst pain possible). A minimal 30% decrease of pain level between baseline and T1 will define the success, and other cases will define the failure of the treatment.

Secondary Outcome Measures

intensity of the pain neuropathic

the intensity of the pain neuropathic component using the Neuropathic Pain Symptom Inventory (NPSI) at T4, T5, and T6 {Bouhassira, 2004 #9}; the NPSI is a 12-item self-administered questionnaire describing the intensity of the symptoms associated with pain neuropathic

Full Information

NCT ID

NCT02137954

First Posted

May 7, 2014

Last Updated

August 27, 2015

Sponsor

Assistance Publique Hopitaux De Marseille

1. Study Identification

Unique Protocol Identification Number

NCT02137954

Brief Title

Efficacy of Lidocaine Versus Placebo in Palliative Care Patients With Opioid-refractory Cancer Pain With Neuropathic Component: a Multicenter, Prospective, Double-blind Randomized Placebo-controlled Study.

Acronym

LIDOSP

Official Title

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Unknown status

Study Start Date

May 2014 (undefined)

Primary Completion Date

June 2016 (Anticipated)

Study Completion Date

September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This is a multicenter, prospective, randomized, placebo-controlled, double-blind, two-parallel groups study comparing lidocaine (experimental group) to placebo (control group). The study protocol was elaborated using the recommendations of the Consolidated Standards of Reporting Trials (CONSORT) Statement.

6. Conditions and Keywords

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

Cancer, Pain With Neuropathic Component

Keywords

cancer, pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

lidocaine

Arm Type

Active Comparator

Arm Description

Lidocaine. Initial dose IV will be 5 mg/kg per day during the first 24 hours the 8 mg/kg per day

Arm Title

placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Lidocaine

Other Intervention Name(s)

Lidocaine. Initial dose IV will be 5 mg/kg per day during the first 24 hours the 8 mg/kg per day

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Analgesic efficacy

Description

Time Frame

40 minutes

Secondary Outcome Measure Information:

Title

intensity of the pain neuropathic

Description

Time Frame

120 minutes

Other Pre-specified Outcome Measures:

Title

raw values of pain levels (NPIS)

Description

raw values of pain levels (NPIS) at each evaluation time, percentage of reduction between the initial level of pain and other evaluation times

Time Frame

40 minutes

Title

tolerance to the treatments

Description

The tolerance to the treatment (lidocaine) will be assessed during the first 48 hours following the treatment administration. Adverse events will be cautiously collected (intensity and discomfort): i) lidocaine: arrhythmia, blurred vision, headache, malaise, tremors, metallic taste, nausea/vomiting, perioral numbness and tingling, sedation, and tinnitus.

Time Frame

48 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient aged 18 years or older Patient suffering from cancer pain refractory to standard opiates (numeric pain intensity scale NPIS >=4/10 after 24 hours of continuous intravenous morphine or oxycodone administration [SOR 2002, analgesics drugs for adults cancer nociceptive pain]), regardless of the nature of the primary cancer] Patient suffering from cancer neuropathic or mixed pain (DNA survey score> = 4 [Bouhassira 2004]) Patient receiving palliative care as defined by French Society of Palliative and Support Care [Charte des Soins Palliatifs, 1996, Act No. 99-477 of 9 June 1999 to guarantee the right of access to palliative care] according to the definition of the World Health Organization (WHO) [World Health Organization. WHO's pain ladder. http://www.who.int/cancer/palliative/painladder/en/. Accessed December 9.2011] Patient with histological diagnosis of cancer, locally advanced or metastatic disease Patient without curative cancer treatment, and with or without palliative anticancer treatment Patient hospitalized in a specific palliative care unit Patient with an estimated survival higher than 48 hours (physician estimation) Patient providing written informed consent for participation prior to any study procedures. Exclusion Criteria: Patient with a known hypersensitivity to lidocaine Patient with a history of porphyria, arrhythmias, disorders of atrioventricular conduction requiring permanent pacing not yet realized, uncontrolled epilepsy, uncontrolled hypertension Patient with hematologic malignancy, abnormal renal, hepatic and cardiac functions Patient with a altered sleepiness (Epworth scale score ≤ 16) Patient with altered cognitive function (TELECOM scale score> 11) [Arsène 2000] Patient not native French speaker Patient defined as vulnerable subject (minor subject, pregnant or nursing woman, subject freedom deprived)

Central Contact Person:

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

Sebastien SALAS, MD

Phone

+33491384408

sebastien.salas@ap-hm.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sebastien SALAS, MD

Organizational Affiliation

- Service d'Oncologie Médicale et de Soins Palliatifs Assistance Publique Hopitaux de Marseille

Official's Role

Principal Investigator

Facility Information:

Facility Name

- Service d'Oncologie Médicale et de Soins Palliatifs Assistance Publique Hopitaux de Marseille

City

Marseille

ZIP/Postal Code

13005

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sebastien Salas, MD

Phone

+3349138408

sebastien.salas@ap-hm.fr

First Name & Middle Initial & Last Name & Degree

sebastien salas, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

25112302

Citation

Salas S, Auquier P, Duffaud F, Garnier SR, Deschamps M, Honore S, Sudour P, Baumstarck K. Efficacy of lidocaine in patients receiving palliative care with opioid-refractory cancer pain with a neuropathic component: study protocol for a randomized controlled study. Trials. 2014 Aug 12;15:318. doi: 10.1186/1745-6215-15-318.

Results Reference

derived

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