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.

Cancer Clinical Trial

— LIDOSP  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02137954
• Other study ID #: 2013-50
• Status: Recruiting
• Phase: Phase 3
• First received: May 7, 2014
• Last updated: August 27, 2015
• Start date: May 2014
• Est. completion date: September 2016

Study information

• Verified date: August 2015
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Sebastien SALAS, MD
• Phone: +33491384408
• Email: sebastien.salas[@]ap-hm.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer
• Pain With Neuropathic Component

Intervention

Drug:
• Lidocaine

• Placebo

Locations

Country	Name	City	State
France	- Service d'Oncologie Médicale et de Soins Palliatifs Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	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	Yes
Primary	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	No
Secondary	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	No