Efficacy of Auricular Acupuncture Therapy Via the Seirin Pyonex Needles in the Prevention of Chemotherapy-Induced Peripheral Neuropathy(CIPN) in Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Incidence of CIPN at the end of the 4th chemotherapy
研究概览
简要总结
Evaluate the Efficacy of Auricular Acupuncture Therapy via the Seirin Pyonex Needles in the Prevention of Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer
详细描述
This is a Phase II Randomised Controlled Clinical Trial to evaluate the efficacy of auricular acupuncture therapy via the Seirin Pyonex Needles in the prevention of chemotherapy-induced peripheral neuropathy in breast cancer.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with breast cancer diagnosed with stage I-III;
- •Planned to receive 4 cycles of taxane chemotherapy and have not taken neurostable drugs within three months;
- •18 years old≤ age≤ 75 years old, female;
- •Subjects voluntarily participate in this trial and sign the informed consent form.
排除标准
- •Patients who have had acupuncture treatment in the past;
- •After examination by a doctor, there is a local infection at or near the acupuncture site, which is not suitable for acupuncture.
- •Platelets< 50,000/μL;
- •Patients with CIPN≥1 grade 1 (NCI-CTCAE);
- •Peripheral neuropathy or other neuropathic pain caused by diabetes mellitus or other factors related to HIV infection.
研究组 & 干预措施
Auricular acupuncture treatment group
On the basis of conventional nursing, patients are treated with bilateral auricular acupuncture points (Seirin Pyonex Needles φ 0.2 mm × 1.2 mm) before chemotherapy.
Specific operation: 1 treatment before each chemotherapy treatment, and 2 treatments a week in the 2nd and 3rd weeks of the chemotherapy interval. The patient was instructed to press the acupuncture point for 3 times/d, the pressure time was 5min, and the local swelling pain was tolerated by the patient. The doctor took the needle out for the patient after leaving it for 3 days. Treatment was continued for 4 cycles of chemotherapy, followed up for 2 months after treatment completion, and routine care was carried out during treatment.
干预措施: Auricular acupuncture treatment (Device)
Sham acupuncture group
The treatment regimen is the same as that of the auricular acupuncture treatment group, but with a sham acupuncture (Seirin Pyonex Needles).
干预措施: Sham acupuncture group (Device)
结局指标
主要结局
Incidence of CIPN at the end of the 4th chemotherapy
时间窗: From date of randomization until the date of he fourth application of taxane chemotherapy (up to 12 weeks)
Incidence of CIPN at the end of the 4th application of taxane chemotherapy (according to NCI-CTCAE V5.0)
次要结局
- Incidence of CIPN at the end of the 3rd chemotherapy(From date of randomization until the date of he fourth application of taxane chemotherapy (up to 12 weeks))
- CIPN neurotoxicity change(From date of randomization until the date of he fourth application of taxane chemotherapy (up to 12 weeks))
- The degree of sensory impairment(From date of randomization until the date of he fourth application of taxane chemotherapy (up to 12 weeks))
- The pain intensity score(From date of randomization until the date of he fourth application of taxane chemotherapy (up to 12 weeks))
- The General Hospital Anxiety/Depression (HAD)(From date of randomization until the date of he fourth application of taxane chemotherapy (up to 12 weeks))