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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002202-37-NL

Enrollment

Registered

2015-09-21

Start date

2016-01-06

Completion date

Unknown

Last updated

2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute oxaliplatin induced neuropathy

Interventions

Trade Name: Lidocaine Hydrochloride Product Name: Lidocaine Product Code: RVG 51673 Pharmaceutical Form: Infusion Pharmaceutical form of the placebo: Infusion Route of administration of the placebo: I

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Receiving other chemotherapeutics in medical history Allergy to amide type of local anesthetics Recent myocardial ischemia ( 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

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of low dose intravenously lidocaine in comparison with placebo in terms of pain relief after the first oxaliplatin administration measured by a numeric rating scale (NRS 0-10;Secondary Objective: 1. Difference in pain scores between placebo and lidocaine administered concomitant with oxaliplatin during and after all cycles of oxaliplatin administration. 2. Does lidocaine administered attenuates systemic inflammatory response measured by plasma cytokine levels of interleukin (IL)-6, IL-8, IL-10, IL-1ß, TNF-a and ICAM-1? 3. To evaluate if lidocaine influences quantative sensory testing (pressure algometry and ice-bucket). 4. To evaluate if lidocaine reduces chronic neuropathic changes measured by the clinical total neuropathy score (TNS), neurophysiologic conductions studies, skin biopsy and measured by a NCI-CTC and EORTC QLQ-CIPN20 questionnaire. 5. Cumulative oxaliplatin dosage. 6. Cumulative analgesics usage. 7. Other secondary outcomes consists of quality of life improvements measured by EORTC QLQ-C30 and patient reported outcome variables for strength and sensory function and DNA/RNA biobanking. ;Primary end point(s): The difference in NRS scores for pain after the first infusion of oxaliplatin and administration of studymedication. The aim is a reduction of 3 points of NRS;Timepoint(s) of evaluation of this end point: Directly after administration of the studymedication	—

Measure

Time frame

Main Objective: To evaluate the efficacy of low dose intravenously lidocaine in comparison with placebo in terms of pain relief after the first oxaliplatin administration measured by a numeric rating scale (NRS 0-10;Secondary Objective: 1. Difference in pain scores between placebo and lidocaine administered concomitant with oxaliplatin during and after all cycles of oxaliplatin administration. 2. Does lidocaine administered attenuates systemic inflammatory response measured by plasma cytokine levels of interleukin (IL)-6, IL-8, IL-10, IL-1ß, TNF-a and ICAM-1? 3. To evaluate if lidocaine influences quantative sensory testing (pressure algometry and ice-bucket). 4. To evaluate if lidocaine reduces chronic neuropathic changes measured by the clinical total neuropathy score (TNS), neurophysiologic conductions studies, skin biopsy and measured by a NCI-CTC and EORTC QLQ-CIPN20 questionnaire. 5. Cumulative oxaliplatin dosage. 6. Cumulative analgesics usage. 7. Other secondary outcomes consists of quality of life improvements measured by EORTC QLQ-C30 and patient reported outcome variables for strength and sensory function and DNA/RNA biobanking. ;Primary end point(s): The difference in NRS scores for pain after the first infusion of oxaliplatin and administration of studymedication. The aim is a reduction of 3 points of NRS;Timepoint(s) of evaluation of this end point: Directly after administration of the studymedication

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Secondary

Measure	Time frame
Secondary end point(s): 1. Difference in pain scores after all cycles of oxaliplatin administration. 2. plasma cytokine levels of interleukin (IL)-6, IL-8, IL-10, IL-1ß, TNF-a and ICAM-1 before and after first dose of oxaliplatin? 3. Results from quantative sensory testing (pressure algometry and ice-bucket). 4. Chronic neuropathic changes measured by the clinical total neuropathy score (TNS), neurophysiologic conductions studies, skin biopsy and measured by a NCI-CTC and EORTC QLQ-CIPN20 questionnaire. 5. Cumulative oxaliplatin dosage. 6. Cumulative analgesics usage. 7. Quality of life improvements measured by EORTC QLQ-C30 and patient reported outcome variables for strength and sensory function. ;Timepoint(s) of evaluation of this end point: Pain scores and patient reported outcomes: before and till 5 days after oxaliplatin infusion Questionnaires EORTC-CIPN20 and NCI-CTC at baseline, before each oxaliplatin infusion and at 3 months follow up. EORTC QLQ-C30 at baseline at 3 months follow up. Physical examination (QST, sock/glove like distribution, and clinical total neuropathy score): at baseline, before fourth and eight oxaliplatin infusion and at 3 months follow up Neurophysiologis studies: at baseline, before fourth and eight oxaliplatin infusion and 3 months follow up Skin biopt at baseline and at 3 months follow up Cumulative oxaliplatin dose and analgesics usage at 3 months	—

Measure

Time frame

Secondary end point(s): 1. Difference in pain scores after all cycles of oxaliplatin administration. 2. plasma cytokine levels of interleukin (IL)-6, IL-8, IL-10, IL-1ß, TNF-a and ICAM-1 before and after first dose of oxaliplatin? 3. Results from quantative sensory testing (pressure algometry and ice-bucket). 4. Chronic neuropathic changes measured by the clinical total neuropathy score (TNS), neurophysiologic conductions studies, skin biopsy and measured by a NCI-CTC and EORTC QLQ-CIPN20 questionnaire. 5. Cumulative oxaliplatin dosage. 6. Cumulative analgesics usage. 7. Quality of life improvements measured by EORTC QLQ-C30 and patient reported outcome variables for strength and sensory function. ;Timepoint(s) of evaluation of this end point: Pain scores and patient reported outcomes: before and till 5 days after oxaliplatin infusion Questionnaires EORTC-CIPN20 and NCI-CTC at baseline, before each oxaliplatin infusion and at 3 months follow up. EORTC QLQ-C30 at baseline at 3 months follow up. Physical examination (QST, sock/glove like distribution, and clinical total neuropathy score): at baseline, before fourth and eight oxaliplatin infusion and at 3 months follow up Neurophysiologis studies: at baseline, before fourth and eight oxaliplatin infusion and 3 months follow up Skin biopt at baseline and at 3 months follow up Cumulative oxaliplatin dose and analgesics usage at 3 months

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Countries

Netherlands

Contacts

Public ContactHead of department Anesthesiology

Radboudumc

Kris.Vissers@radboudumc.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026