Genetic Predictors to Acupuncture Response for Arthralgia Induced by Aromatase Inhibitors in Patients With Breast Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Changes in arthralgia scores were measured by the BPI
研究概览
简要总结
Purpose:Acupuncture for arthralgia induced by aromatase inhibitors in patients with breast cancer associated with screening of SNPs.
详细描述
Aromatase inhibitor-induced arthralgia (AIA) is the most common side effect of aromatase inhibitors (AIs) used in breast cancer , may cause poor adherence to AIs. Studies have shown that acupuncture has a certain therapeutic effect on AIA in breast cancer. In this study, acupuncture was used to relieve the symptoms of arthralgia in patients, and the efficacy of acupuncture was observed by using relevant scales. Currently, studies have shown that AIA in breast cancer patients is related to some biological factors.
At the same time, we collected peripheral blood samples of patients, combined with the reported relevant literature, screened out the single nucleotide polymorphisms(SNP) related to AIA and to guide acupuncture treatment of aromatase Inhibitors induced arthralgia, balance the toxicity of endocrine therapy, and improve compliance and effectiveness.
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
- •History of stage I-III breast cancer and free of disease by clinical examination;Currently receiving aromatase inhibitors (Anastrozole, Letrozole, or Exemestane) treatment;
- •AI-assisted treatment has lasted for more than one month, and there are obvious symptoms of arthralgia ;
- •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, but not patients with distant metastasis;
- •The basic indexes were consistent, and the blood routine and ECG were normal.
排除标准
- •Patients with needle phobia;
- •Low platelet count (<50000); comorbidity with a bleeding disorder; comorbidity with thyroid dysfunction; pregnancy; haemoglobin levels <10 g/dl and haematocrit <30; anaemia on active pharmacological treatment orreceiving blood transfusion or steroids;
- •Lymphoedematous of limbs;
- •Patients have a history of acupuncture treatment for 6 months;
- •Patients were reluctant to participate in the study;
- •A prior history of inflammation, metabolic disease, or neurotic joints, except for previous treatment with bisphosphonates, steroids, or opioid analgesics.
结局指标
主要结局
Changes in arthralgia scores were measured by the BPI
时间窗: 52 weeks
Changes in arthralgia scores were measured by the Brief Pain Inventory (BPI) before and after acupuncture treatment.
次要结局
- Changes in arthralgia scores were measured by the WOMAC scales(52 weeks)
研究者
Jiuda Zhao
Professor
Affiliated Hospital of Qinghai University