Comparative Clinical Study Evaluating the Possible Efficacy of Duloxetine, Gabapentin and Lacosamide on Oxaliplatin-Induced Peripheral Neuropathy in Cancer Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 2
- 主要终点
- McGill Pain Questionnaire
研究概览
简要总结
This study aims to investigate the possible efficacy of duloxetine, gabapentin and lacosamide on oxaliplatin-induced peripheral neuropathy in patients with gastrointestinal cancer.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
double blind
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A) Adults ≥ 18 years old male and female patients. B) Patients with gastrointestinal cancer receiving oxaliplatin chemotherapy
排除标准
- •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.
结局指标
主要结局
McGill Pain Questionnaire
时间窗: every 2 weeks
questionnaire
12-item neurotoxicity questionnaire
时间窗: every 4 weeks
questionnaire
EORTC Core Quality of Life questionnaire
时间窗: up to 6 months
questionnaire
Common Terminology Criteria for Adverse Events
时间窗: every 4 weeks
questionnaire
次要结局
- Hemeoxygenase-1(up to 6 months)
- Neurofilament light chain (NfL)(up to 6 months)
- Nuclear factor- kappa B (NF- κB)(up to 6 months)
- Neurotensin (NT)(up to 6 months)
研究者
Sally Said Mohamed Tantawy
Clinical Pharmacist
Tanta University