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Trial Title:
Comparative Clinical Study Evaluating the Possible Efficacy of Duloxetine, Gabapentin and Lacosamide on Oxaliplatin-Induced Peripheral Neuropathy in Cancer Patients
NCT ID:
NCT05510856
Condition:
Oncology
Conditions: Official terms:
Peripheral Nervous System Diseases
Lacosamide
Gabapentin
Duloxetine Hydrochloride
Conditions: Keywords:
oxaliplatin,peripheral neuropathy
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Double (Participant, Investigator)
Masking description:
double blind
Intervention:
Intervention type:
Other
Intervention name:
Duloxetine
Description:
Duloxetine 30mg / day for 12 cycles (up to 6 months)
Arm group label:
Duloxetine
Intervention type:
Other
Intervention name:
Gabapentin
Description:
Gabapentin 300 mg / day for 12 cycles (up to 6 months)
Arm group label:
Gabapentin
Intervention type:
Other
Intervention name:
Lacosamide
Description:
Lacosamide 50 mg / day for 12 cycles (up to 6 months)
Arm group label:
Lacosamide
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).
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Oncology Department, Tanta University
Address:
City:
Tanta
Zip:
040
Country:
Egypt
Status:
Recruiting
Start date:
September 1, 2022
Completion date:
September 2024
Lead sponsor:
Agency:
Tanta University
Agency class:
Other
Source:
Tanta University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05510856
