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

Oncology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05510856
• Other study ID #: oxaliplatin induced neuropathy
• Status: Recruiting
• Phase: Phase 4
• Start date: September 1, 2022
• Est. completion date: September 2024

Study information

• Verified date: October 2022
• Source: Tanta University
• Contact: Sally Said, MSC
• Phone: 01004640401
• Email: sallysaid016[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: September 2024
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Oncology
• Peripheral Nervous System Diseases

Intervention

Other:
• Duloxetine
Duloxetine 30mg / day for 12 cycles (up to 6 months)
• Gabapentin
Gabapentin 300 mg / day for 12 cycles (up to 6 months)
• Lacosamide
Lacosamide 50 mg / day for 12 cycles (up to 6 months)

Locations

Country	Name	City	State
Egypt	Oncology Department, Tanta University	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	McGill Pain Questionnaire	questionnaire	every 2 weeks
Primary	12-item neurotoxicity questionnaire	questionnaire	every 4 weeks
Primary	EORTC Core Quality of Life questionnaire	questionnaire	up to 6 months
Primary	Common Terminology Criteria for Adverse Events	questionnaire	every 4 weeks
Secondary	Neurofilament light chain (NfL)	biological biomarker	up to 6 months
Secondary	Nuclear factor- kappa B (NF- ?B)	biological biomarker	up to 6 months
Secondary	Neurotensin (NT)	biological biomarker	up to 6 months
Secondary	Hemeoxygenase-1	biological biomarker	up to 6 months