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.

NCT02137954 | Unknown Phase 3

• 1 other identifier: 2013-50
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Pain With Neuropathic Component

Keywords

cancer; pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• intensity of the pain neuropathic

  120 minutes

Other Outcomes (2)

• raw values of pain levels (NPIS)

  40 minutes

• tolerance to the treatments

  48 hours

Study Arms (2)

lidocaine

ACTIVE COMPARATOR

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

Drug: Lidocaine

placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Lidocaine DRUG

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

lidocaine

Placebo DRUG

placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

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

Marseille, 13005, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 25112302 DERIVED

MeSH Terms

Conditions

Neoplasms; Pain

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Sebastien SALAS, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sebastien SALAS, MD

CONTACT

+33491384408; sebastien.salas@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2014
• First Posted: May 14, 2014
• Study Start: May 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: September 1, 2016
• Last Updated: August 28, 2015

Record last verified: 2015-08

Locations

FR (1)