临床试验/NCT05834231

NCT05834231尚未招募1 期

Efficacy of Memantine in Prevention of Oxaliplatin-induced Peripheral Neurotoxicity

Mansoura University0 个研究点目标入组 60 人开始时间: 2023年8月最近更新: 2023年4月28日

适应症

干预措施

试验速览

阶段: 1 期
状态: 尚未招募
发起方: Mansoura University
入组人数: 60
主要终点: Incidence of chemotherapy induced-peripheral neuropathy using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

Memantine is a drug for the management of Alzheimer's Disease (AD) due to its promising neuroprotective properties. We hypothesize that Memantine possesses a beneficial role against chemotherapy-induced neuronal damages.

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, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•histologically confirmed diagnosis of stage III colorectal cancer performance status < 2 according to Eastern Cooperative Oncology Group (ECOG) score adequate renal function (glomerular filtration rate ≥ 90)

排除标准

•preexisting neuropathic or brain disorders, a previous use of chemotherapeutic agents including oxaliplatin use of drugs reported to have neuroprotective role

研究组 & 干预措施

Intervention

Active Comparator

干预措施: Memantine (Drug)

Control

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

Incidence of chemotherapy induced-peripheral neuropathy using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria

时间窗: 6 months

次要结局

未报告次要终点

研究者

发起方

Mansoura University

申办方类型

Other

责任方

Principal Investigator

主要研究者

Noha Mansour

Lecturer of Clinical Pharmacy

Mansoura University

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