Comparative Clinical Study Evaluating the Possible Efficacy of Duloxetine, Gabapentin and Lacosamide on Oxaliplatin-Induced Peripheral Neuropathy in Cancer Patients
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Detailed Description
This is a randomized, double-blind parallel study that will be conducted on patients with oxaliplatin induced peripheral neuropathy with gastrointestinal cancer.
This study will be done on 90 patients with gastrointestinal cancer (colon or gastric or pancreatic) cancer on standard CAPEOX regimen who will divided into 3 groups:
Group 1: 30 Patients who will receive standard chemotherapy plus duloxetine 30 mg/day for 8 cycles (up to 6 months).
Group 2: 30 Patients who will receive standard chemotherapy plus gabapentin 300 mg/day for 8 cycles (up to 6 months).
Group 3: 30 Patients who will receive standard chemotherapy plus lacosamide 50 mg/day for 8 cycles (up to 6 months).
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Duloxetine group 1 |
Other: Duloxetine
Duloxetine 30mg / day for 8 cycles (up to 6 months)
|
Experimental: Gabapentin group 2 |
Other: Gabapentin
Gabapentin 300 mg / day for 8 cycles (up to 6 months)
|
Experimental: Lacosamide group 3 |
Other: Lacosamide
Lacosamide 50 mg / day for 8 cycles (up to 6 months)
|
Outcome Measures
Primary Outcome Measures
- Brief Pain Inventory-Short Form [every 2 weeks]
questionnaire
- 12-item neurotoxicity questionnaire [every 2 weeks]
questionnaire
- EORTC Core Quality of Life questionnaire [up to 6 months]
questionnaire
Secondary Outcome Measures
- Neurofilament light chain (NfL) [up to 6 months]
biological biomarker
- Nuclear factor- kappa B (NF- κB) [up to 6 months]
biological biomarker
- Neurotensin (NT) [up to 6 months]
biological biomarker
- Malondialdehyde (MDA) [up to 6 months]
biological biomarker
Eligibility Criteria
Criteria
Inclusion Criteria:
-
- Adults ≥ 18 years old male and female patients. B) Patients with gastrointestinal cancer receiving oxaliplatin chemotherapy
Exclusion Criteria:
-
- Preexisting neuropathic or brain disorders. B) Previous use of chemotherapeutic agents including taxanes, platinum, vinca alkaloids, and bortezomib.
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Concomitant use of drugs reported to have neuroprotective role and analgesics.
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Patients with diabetes, uncontrolled hypertension, congestive heart failure, drug addiction and patients who were receiving tamoxifen.
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Patients with abnormal renal function tests (serum creatinine ≤ 30 ml/min) or liver function tests (≥ 3 times the upper normal range).
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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.
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Pregnancy and lactating women. I) Uncooperative patients and patients who have psychological problems or on antipsychotic medications.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Tanta University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- oxaliplatin induced neuropathy