Precision Acupuncture in the Treatment of Peripheral Neuropathy After Taxanes Chemotherapy in Breast Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- FACT/GOG-Ntx
研究概览
简要总结
Precision Acupuncture in the Treatment of Peripheral Neuropathy After Taxane Chemotherapy in Breast Cancer
详细描述
Associated peripheral neuropathy in breast cancer patients has a significant impact on their quality of life and treatment compliance. Many studies have shown that acupuncture has a certain therapeutic effect on peripheral neuropathy. Studies have shown that taxane induced peripheral neuropathy in breast cancer is related to genetic factors. Based on SNPs related to peripheral neuropathy, this study screened SNPs related to peripheral neuropathy caused by taxane drugs, and established a prognostic model.
Eligible patients diagnosed with stage I, II or IIIA breast cancer and experiencing peripheral neuropathy for at least 2 weeks were assessed by the Functional Assessment of Cancer Therapy/Gynaecologic Oncology Group-Neurotoxicity，FACT/GOG-Ntx) and the European Organisation of Research and Treatment of Cancer Quality of Life Questionnaire-CIPN twenty-item scale(EORTC QLQ-CIPN20). Likert level 5 and level 4 scores were used for all items in the above two scales. The investigators will temporarily divide the study into a group, and the investigators will increase the group if necessary. Laboratory personnel were blinded to all clinical and outcome data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •The patient was at least 18 years old and had reported grade 1 or higher neuropathic symptoms for more than 2 weeks;
- •Patients were screened for eligibility by the investigator prior to enrollment, including verification of baseline neuropathic symptoms.
- •Patients had a diagnosis of stage I, II, or IIIA breast cancer;
- •Have completed at least 2 weeks of chemotherapy;
- •Higher scores indicate more severe symptoms;
- •Voluntarily participate in the clinical trial and sign the informed consent form after informed consent (patients voluntarily accept the treatment and give informed consent);
- •Eastern Cooperative Oncology Group (ECOG ) score of physical condition (0-1);
- •Patients with previous local recurrence were eligible;
- •The basic indexes were consistent, and the blood routine and ECG were normal.
排除标准
- •patients with needle phobia;
- •Low platelet count (<50 000); co-morbidity with a bleeding disorder; comorbidity with thyroid dysfunction; pregnancy; haemoglobin levels <10 g/dl and haematocrit <30; anaemia on active pharmacological treatment or receiving blood transfusion or steroids;
- •having metastatic or recurrent disease, history of preexisting peripheral neuropa- thy prior to chemotherapy, uncontrolled seizure disorder, unstable cardiac disease or myocardial infarction within 6 months prior to study entry;
- •Being pregnant or nursing, or having used acupuncture for peripheral neuropathy within 6 months prior to study entry;
- •Life expectancy <6 months;
- •Lymphedema of limbs;
结局指标
主要结局
FACT/GOG-Ntx
时间窗: 6
Patients self-reported FACT/ GOG-NTX at 6 weeks (end of treatment).
次要结局
未报告次要终点
研究者
Jiuda Zhao
Professor
Affiliated Hospital of Qinghai University