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)

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.

Study Overview

• Status: Unknown
• Conditions: Cancer; Pain With Neuropathic Component
• Intervention / Treatment: Drug: Placebo; Drug: Lidocaine

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13005
    • Recruiting
    • - Service d'Oncologie Médicale et de Soins Palliatifs Assistance Publique Hopitaux de Marseille
    • Principal Investigator: Sebastien Salas, MD
    • Contact: Sebastien Salas, MD; Phone Number: +3349138408; Email: sebastien.salas@ap-hm.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Drug: Placebo
Active Comparator: lidocaine; Lidocaine. Initial dose IV will be 5 mg/kg per day during the first 24 hours the 8 mg/kg per day	Drug: Lidocaine; Other Names: Lidocaine. Initial dose IV will be 5 mg/kg per day during the first 24 hours the 8 mg/kg per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	40 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	120 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
raw values of pain levels (NPIS)	raw values of pain levels (NPIS) at each evaluation time, percentage of reduction between the initial level of pain and other evaluation times	40 minutes
tolerance to the treatments	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.	48 hours

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille
• Investigators: Principal Investigator: Sebastien SALAS, MD, - Service d'Oncologie Médicale et de Soins Palliatifs Assistance Publique Hopitaux de Marseille

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Anticipated): June 1, 2016
• Study Completion (Anticipated): September 1, 2016

Study Registration Dates

• First Submitted: May 7, 2014
• First Submitted That Met QC Criteria: May 13, 2014
• First Posted (Estimate): May 14, 2014

Study Record Updates

• Last Update Posted (Estimate): August 28, 2015
• Last Update Submitted That Met QC Criteria: August 27, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: pain; cancer
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Cancer Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 2013-50