NCT03048591Unknown不适用
The Exploratory Study of Electroacupuncture in the Treatment of Peripheral Neuropathy Induced by Platinum Based Chemotherapy Drugs
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 72
- 主要终点
- Quality of life questionnaire to assess chemotherapy-induced peripheral neuropathy (QLQ-CIPN20)
研究概览
简要总结
Through the research to confirm the effectiveness and safety of using electroacupuncture in the treatment of chemotherapy-induced peripheral neuropathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The histopathological and / or cellular pathology results prove malignancy of the tumor and the patient has received chemotherapy treatment before.
- •15weeks after the completion of chemotherapy, the limbs are still feeling abnormal and the symptoms fulfill World Health Organization (WHO) grade 2 or more.
- •zubrod - Eastern Cooperative Oncology Group-WHO (ZPS) grade 0-2, cardiac function, liver function and renal function are not significantly abnormal, the survival period of the patient is expected to be more than 6 months.
- •Gender unrestricted, aged between 18 to 80 years old.
- •Voluntary participation in the study, will to sign informed consent, willing to comply with randomized grouping, will to follow-up.
排除标准
- •Patients who suffer from peripheral neuropathy due to infection, radiotherapy, HIV, chronic alcoholism, hypothyroidism, diabetes, paraneoplastic syndrome or other diseases; or are suffering from nervous system diseases.
- •Patients who are being treated with other drugs that may lead to neurotoxicity .
- •Patients with blood coagulation disorder.
- •Pregnancy and lactating women.
- •Patients with infection, scarring or defects near the acupoint sites.
- •Received intervention for the prevention and treatment of peripheral neuropathy 2 weeks before screening or has received traditional Chinese medicine (acupuncture, moxibustion, cupping, Chinese medicine therapy one month before.
研究组 & 干预措施
Electroacupuncture group
Experimental
干预措施: electroacupuncture (Device)
control group
No Intervention
结局指标
主要结局
Quality of life questionnaire to assess chemotherapy-induced peripheral neuropathy (QLQ-CIPN20)
时间窗: 6 weeks
次要结局
- Functional Assessment of Cancer Treatment - General scale（FACT-G）(6 weeks)
研究者
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