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
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
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