Drug Repurposing for the Prevention of Chemotherapy-induced Peripheral Neuropathy (CIPN)
试验速览
- 阶段
- 2 期
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Percentage of grade 2-4 neurotoxicity in both arms
研究概览
简要总结
Chemotherapy cause many adverse events including induction of peripheral neuropathy. Metformin, the AMPK activator, was found to have protective effect against chemotherapy induced peripheral neuropathy in mouse model and in clinical trials as well. There are different hypothesized mechanisms through which metformin does the protective effect. Such as enhancing mitochondrial activity, reduction of ROS and nitric oxide and activation of AMPK.
详细描述
Chemotherapy can cause a variety of side effects. One of the most common side effects is Chemotherapy induced peripheral neuropathy (CIPN), it commonly caused by Paclitaxel chemotherapy which is usually used in the treatment of breast cancer. Metformin which is known as a safe anti-diabetic drug, was found to have a protective effect on neurons. It gave positive results in chemotherapy induced peripheral neuropathy in mouse models and in some clinical trials
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)
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
- •Age (18-75) male and female patients
- •Scheduled to be treated with single agent Paclitaxel
- •Performance status according to Eastern Cooperative oncology group (ECOG) <
- •Patients who are willing and able to review and provide written consent, patients who can read the questionnaires
排除标准
- •Previous exposure to chemotherapy drugs that cause neuropathy, patients treated with medications that increase the risk of neuropathy like amiodarone, Colchicine, metronidazole, phenytoin.
- •Patients with impaired liver functions or kidney functions.
- •Patients with a history of any serious adverse events or interaction or hypersensitivity to Metformin.
- •Pregnant or lactating females.
- •Patients who are using metformin for any other cause.
- •Patients with sensory or motor neuropathy of any grade prior to enrollment.
研究组 & 干预措施
Metformin group
1 gm metformin tablet administered twice daily for 3 months
干预措施: Metformin (Drug)
Metformin-free
1 placebo tablet administered twice daily for 3 months
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of grade 2-4 neurotoxicity in both arms
时间窗: 3 months
Measured by NCI-CTCAE system
次要结局
- Percentage of other treatment related common adverse events in both arms.(3 months)
- Difference in biological markers in both arms.(3 months)
- Percentage of Qulaity of Life (QOL) deterioration in both arms(3 months)
研究者
Sara Araby Ramadan Aly Mosa
Bsc.
Cairo University