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

NCT05510856 | Completed Phase 4

• 1 other identifier: oxaliplatin induced neuropathy
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Oncology

Keywords

oxaliplatin,peripheral neuropathy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Neurofilament light chain (NfL)

  up to 6 months

• Nuclear factor- kappa B (NF- κB)

  up to 6 months

• Neurotensin (NT)

  up to 6 months

• Hemeoxygenase-1

  up to 6 months

Study Arms (3)

Duloxetine

EXPERIMENTAL

group 1

Other: Duloxetine

Gabapentin

EXPERIMENTAL

group 2

Other: Gabapentin

Lacosamide

EXPERIMENTAL

group 3

Other: Lacosamide

Interventions

Duloxetine OTHER

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

Duloxetine

Gabapentin OTHER

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

Gabapentin

Lacosamide OTHER

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

Lacosamide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Oncology Department, Tanta University

Tanta, 040, Egypt

Location

MeSH Terms

Conditions

Neoplasms; Peripheral Nervous System Diseases

Interventions

Duloxetine Hydrochloride; Gabapentin; Lacosamide

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Amines; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Acetamides; Amides; Acetates

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Pharmacist

Study Record Dates

• First Submitted: August 13, 2022
• First Posted: August 22, 2022
• Study Start: September 1, 2022
• Primary Completion: September 30, 2024
• Study Completion: October 15, 2024
• Last Updated: November 22, 2024

Record last verified: 2024-11

Locations

EG (1)