Skip to main content
Clinical Trials/EUCTR2015-002202-37-NL
EUCTR2015-002202-37-NLActive, not recruitingNot Applicable

Pilot study: Is concomitant administration of lidocaine during oxaliplatin infusion able to prevent pain as a result of oxaliplatin induced acute neuropathy? - LiO

radboudumc0 sitesStarted: September 21, 2015Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
radboudumc

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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

Investigators

Sponsor
radboudumc

Similar Trials