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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05510856
Other study ID # oxaliplatin induced neuropathy
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


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
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