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

Phase 4
Recruiting
Conditions
Pijngeneeskunde
Oxaliplatin induced nerve pain
10017991
Registration Number
NL-OMON42676
Lead Sponsor
Academisch Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
24
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.

Exclusion Criteria

Receiving other chemotherapeutics in medical history
Allergy to amide type of local anesthetics
Recent myocardial ischemia (<6 months)
Cardiale arrhytmias
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
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Difference in NRS before and after the first oxaliplatin infusion</p><br>
Secondary Outcome Measures
NameTimeMethod
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