Comparative Clinical Study Evaluating the Possible Efficacy of Duloxetine, Gabapentin and Lacosamide on Oxaliplatin-Induced Peripheral Neuropathy in Cancer Patients

Study Overview
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Brief Summary
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This study aims to investigate the possible efficacy of duloxetine, gabapentin and lacosamide on oxaliplatin-induced peripheral neuropathy in patients with gastrointestinal cancer.

Detailed Description
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This is a randomized, double-blind,controlled, parallel study that will be conducted on patients with oxaliplatin induced peripheral neuropathy with gastrointestinal cancer. This study will be done on 93 patients with gastrointestinal cancer (colon or gastric or pancreatic) cancer on standard FOLFOX-4 regimen who will divided into 3 groups: Group 1: 31 Patients who will receive standard chemotherapy plus duloxetine 30 mg/day for 12 cycles (up to 6 months). Group 2: 31 Patients who will receive standard chemotherapy plus gabapentin 300 mg/day for 12 cycles (up to 6 months). Group 3: 31 Patients who will receive standard chemotherapy plus lacosamide 50 mg/day for 12 cycles (up to 6 months).

Official Title
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Comparative Clinical Study Evaluating the Possible Efficacy of Duloxetine, Gabapentin and Lacosamide on Oxaliplatin-Induced Peripheral Neuropathy in Cancer Patients

Conditions
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Oncology

Intervention / Treatment
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* Other: Duloxetine
* Other: Gabapentin
* Other: Lacosamide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A) Adults ≥ 18 years old male and female patients. B) Patients with gastrointestinal cancer receiving oxaliplatin chemotherapy Exclusion Criteria: A) Preexisting neuropathic or brain disorders. B) Previous use of chemotherapeutic agents including taxanes, platinum, vinca alkaloids, and bortezomib. C) Concomitant use of drugs reported to have neuroprotective role and analgesics. D) Patients with diabetes, uncontrolled hypertension, congestive heart failure, drug addiction and patients who were receiving tamoxifen. E) Patients with abnormal renal function tests (serum creatinine ≤ 30 ml/min) or liver function tests (≥ 3 times the upper normal range). F) Participants with a documented medical history of neuropathy. G) Concomitant use of other antidepressants, anticonvulsants, high-dose vitamin supplements or drugs known to influence serotonin levels. H) Pregnancy and lactating women. I) Uncooperative patients and patients who have psychological problems or on antipsychotic medications.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Duloxetine<br>group 1 | Other: Duloxetine<br>* Duloxetine 30mg / day for 12 cycles (up to 6 months)<br>|
| Experimental: Gabapentin<br>group 2 | Other: Gabapentin<br>* Gabapentin 300 mg / day for 12 cycles (up to 6 months)<br>|
| Experimental: Lacosamide<br>group 3 | Other: Lacosamide<br>* Lacosamide 50 mg / day for 12 cycles (up to 6 months)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| McGill Pain Questionnaire | questionnaire | every 2 weeks | 
| 12-item neurotoxicity questionnaire | questionnaire | every 4 weeks | 
| EORTC Core Quality of Life questionnaire | questionnaire | up to 6 months | 
| Common Terminology Criteria for Adverse Events | questionnaire | every 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurofilament light chain (NfL) | biological biomarker | up to 6 months | 
| Nuclear factor- kappa B (NF- κB) | biological biomarker | up to 6 months | 
| Neurotensin (NT) | biological biomarker | up to 6 months | 
| Hemeoxygenase-1 | biological biomarker | up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oxaliplatin,peripheral neuropathy