Back to resultsComparative Clinical Study Evaluating the Possible Efficacy of Duloxetine, Gabapentin and Lacosamide on Oxaliplatin-Induced Peripheral Neuropathy in Cancer Patients
Primary Purpose
Oncology
Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Duloxetine
Gabapentin
Lacosamide
Sponsored by
About this trial
This is an interventional prevention trial for Oncology focused on measuring oxaliplatin,peripheral neuropathy
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.
Sites / Locations
- Oncology Department, Tanta UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Duloxetine
Gabapentin
Lacosamide
Arm Description
group 1
group 2
group 3
Outcomes
Primary Outcome Measures
McGill Pain Questionnaire
questionnaire
12-item neurotoxicity questionnaire
questionnaire
EORTC Core Quality of Life questionnaire
questionnaire
Common Terminology Criteria for Adverse Events
questionnaire
Secondary Outcome Measures
Neurofilament light chain (NfL)
biological biomarker
Nuclear factor- kappa B (NF- κB)
biological biomarker
Neurotensin (NT)
biological biomarker
Hemeoxygenase-1
biological biomarker
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05510856
Brief Title
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oncology
Keywords
oxaliplatin,peripheral neuropathy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
double blind
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Duloxetine
Arm Type
Experimental
Arm Description
group 1
Arm Title
Gabapentin
Arm Type
Experimental
Arm Description
group 2
Arm Title
Lacosamide
Arm Type
Experimental
Arm Description
group 3
Intervention Type
Other
Intervention Name(s)
Duloxetine
Intervention Description
Duloxetine 30mg / day for 12 cycles (up to 6 months)
Intervention Type
Other
Intervention Name(s)
Gabapentin
Intervention Description
Gabapentin 300 mg / day for 12 cycles (up to 6 months)
Intervention Type
Other
Intervention Name(s)
Lacosamide
Intervention Description
Lacosamide 50 mg / day for 12 cycles (up to 6 months)
Primary Outcome Measure Information:
Title
McGill Pain Questionnaire
Description
questionnaire
Time Frame
every 2 weeks
Title
12-item neurotoxicity questionnaire
Description
questionnaire
Time Frame
every 4 weeks
Title
EORTC Core Quality of Life questionnaire
Description
questionnaire
Time Frame
up to 6 months
Title
Common Terminology Criteria for Adverse Events
Description
questionnaire
Time Frame
every 4 weeks
Secondary Outcome Measure Information:
Title
Neurofilament light chain (NfL)
Description
biological biomarker
Time Frame
up to 6 months
Title
Nuclear factor- kappa B (NF- κB)
Description
biological biomarker
Time Frame
up to 6 months
Title
Neurotensin (NT)
Description
biological biomarker
Time Frame
up to 6 months
Title
Hemeoxygenase-1
Description
biological biomarker
Time Frame
up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sally Said, MSC
Phone
01004640401
Email
sallysaid016@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Osama Ibrahim, phd
Phone
01001880735
Email
osamamhi@hotmail.com
Facility Information:
Facility Name
Oncology Department, Tanta University
City
Tanta
ZIP/Postal Code
040
Country
Egypt
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Comparative Clinical Study Evaluating the Possible Efficacy of Duloxetine, Gabapentin and Lacosamide on Oxaliplatin-Induced Peripheral Neuropathy in Cancer Patients
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