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

Phase 4

Completed

• Conditions: Oncology
• Interventions: Other: Lacosamide; Other: Gabapentin; Other: Duloxetine

• Registration Number: NCT05510856
• Lead Sponsor: Tanta University

Brief Summary

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

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-08-13
• Study First Submitted QC: 2022-08-19
• Study First Posted: 2022-08-22
• Study Start: 2022-09-01
• Primary Completion: 2024-09-30
• Study Completion: 2024-10-15
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

Inclusion Criteria

• A) Adults ≥ 18 years old male and female patients. B) Patients with gastrointestinal cancer receiving oxaliplatin chemotherapy

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lacosamide	Lacosamide	group 3
Gabapentin	Gabapentin	group 2
Duloxetine	Duloxetine	group 1

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Neurotensin (NT)	up to 6 months	biological biomarker
Hemeoxygenase-1	up to 6 months	biological biomarker
Neurofilament light chain (NfL)	up to 6 months	biological biomarker
Nuclear factor- kappa B (NF- κB)	up to 6 months	biological biomarker

Trial Locations

Locations (1)

Oncology Department, Tanta University; 🇪🇬 Tanta, Egypt