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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05510856

Enrollment

Registered

2022-08-22

Start date

2022-09-01

Completion date

2024-10-15

Last updated

2024-11-22

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

Conditions

Oncology

Keywords

oxaliplatin,peripheral neuropathy

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).

Interventions

OTHERDuloxetine

Duloxetine 30mg / day for 12 cycles (up to 6 months)

OTHERGabapentin

Gabapentin 300 mg / day for 12 cycles (up to 6 months)

OTHERLacosamide

Lacosamide 50 mg / day for 12 cycles (up to 6 months)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Masking description

double blind

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Common Terminology Criteria for Adverse Events	every 4 weeks	questionnaire
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

Secondary

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026