Clinical trial NCT05510856: Comparative Clinical Study Evaluating the Possible Efficacy of Duloxetine, Gabapentin and Lacosamide on Oxaliplatin-Induced Peripheral Neuropathy in Cancer Patients
Official title: Comparative Clinical Study Evaluating the Possible Efficacy of Duloxetine, Gabapentin and Lacosamide on Oxaliplatin-Induced Peripheral Neuropathy in Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Oncology
Keywords: oxaliplatin,peripheral neuropathy
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-08-22
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility criteria: 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.

Primary outcomes:
measure: McGill Pain Questionnaire
timeFrame: every 2 weeks
measure: 12-item neurotoxicity questionnaire
timeFrame: every 4 weeks
measure: EORTC Core Quality of Life questionnaire
timeFrame: up to 6 months
measure: Common Terminology Criteria for Adverse Events
timeFrame: every 4 weeks
Secondary outcomes:
measure: Neurofilament light chain (NfL)
timeFrame: up to 6 months
measure: Nuclear factor- kappa B (NF- κB)
timeFrame: up to 6 months
measure: Neurotensin (NT)
timeFrame: up to 6 months
measure: Hemeoxygenase-1
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Oncology Department, Tanta University
Study officials:
References: