Is concomitant administration of lidocaine during oxaliplatin infusion able to prevent acute nervepain as a result of oxaliplatin?

• Conditions: Acute oxaliplatin induced neuropathy; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2015-002202-37-NL
• Lead Sponsor: radboudumc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-21
• Last Update Posted: 18 January 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Subjects with stage II to IV colorectal adenocarcinoma, who are scheduled to receive 6-8 cycles of oxaliplatin 130 mg/m2 every 3 weeks .
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 16
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

Receiving other chemotherapeutics in medical history
Allergy to amide type of local anesthetics
Recent myocardial ischemia (<6 months)
Renal function disorders (MDRD < 60)
Liver failure (bilirubine > 1,5x upper limit of normal)
Adequate hematologic parameters
Hypokaliemia
Pregnancy or lactating
Use of anti-arythmic drugs (flecainide)
Pre-existing form of neuropathy (polyneuropathy or small fibre neuropathy)
History of chronic pain and opioid use
Risk factors for CIPN: alcoholism, diabetes mellitus
No written informed consent by patient

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified