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

T

Tanta University

Status and phase

Enrolling
Phase 4

Conditions

Oncology

Treatments

Other: Lacosamide
Other: Duloxetine
Other: Gabapentin

Study type

Interventional

Funder types

Other

Identifiers

NCT05510856
oxaliplatin induced neuropathy

Details and patient eligibility

About

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

Full 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).

Enrollment

90 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

90 participants in 3 patient groups

Duloxetine
Experimental group
Description:
group 1
Treatment:
Other: Duloxetine
Gabapentin
Experimental group
Description:
group 2
Treatment:
Other: Gabapentin
Lacosamide
Experimental group
Description:
group 3
Treatment:
Other: Lacosamide

Trial contacts and locations

1

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Central trial contact

Osama Ibrahim, phd; Sally Said, MSC

Data sourced from clinicaltrials.gov

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