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.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Cancer Pain With Neuropathic Component

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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lidocaine

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

Group Type ACTIVE_COMPARATOR

Lidocaine

Intervention Type DRUG

placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Lidocaine

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No