Clinical trial NCT02137954: 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.
Official 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cancer
Pain With Neuropathic Component
Keywords: cancer
pain
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2014-05-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Analgesic efficacy
timeFrame: 40 minutes
Secondary outcomes:
measure: intensity of the pain neuropathic
timeFrame: 120 minutes
Other outcomes:
measure: raw values of pain levels (NPIS)
timeFrame: 40 minutes
measure: tolerance to the treatments
timeFrame: 48 hours
Locations:
city: Marseille
country: France
facility: - Service d'Oncologie Médicale et de Soins Palliatifs Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: - Service d'Oncologie Médicale et de Soins Palliatifs Assistance Publique Hopitaux de Marseille
name: Sebastien SALAS, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.