A Multi-center,Randomized Controlled Clinical Trial: the Effect of Acupuncture in Prevention and Treatment of Chemotherapy-induced Nausea and Vomiting on Patients With Malignancy
试验速览
- 阶段
- 不适用
- 入组人数
- 136
- 主要终点
- Change from Baseline in severity of nausea and vomiting at 21 days
研究概览
简要总结
Nausea and vomiting are the most common symptoms experienced by cancer patients after chemotherapy. Some patients have to endure such unpleasant symptoms even after using of antiemetic or anti-vomiting medications.The purpose of this study is to assess the therapeutic effects and safety of acupuncture for chemotherapy-induced nausea and vomiting on patients with malignancy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with definite pathological diagnosis of lung cancer, breast cancer, and gynecological cancer.They haven't receive any chemotherapy or radiotherapy treatment for three months prior to join this study.
- •Patients will receive chemotherapy treatment which included Cisplatin, anthracycline or taxane during the study period.
- •ECOG score is between 0 and
- •The patients are diagnosed with insufficiency of spleen-qi and stomach-qi,reverse ascending of Stomach-Qi in traditional Chinese medicine theory.
- •The expected lifetime of the patient is longer than 6 months.
- •Patients willing to participate in the study and sign the consent form.
排除标准
- •Patients have serious disease in cardiovascular system ,liver system,kidney system, immune systems and hemopoietic system.
- •Pregnant and lactating women.
- •Patients have intractable vomiting caused by malignant brain metastases, intracranial hypertention, digestive tract obstruction, severe liver or Renal dysfunction, brain tumors, cerebrovascular disease, or other reasons.
- •Patients with Coagulopathy, thrombocytopenia, or suffering from bleeding disorders.
- •Patients have been definitely diagnosed with depression, anxiety disorders and psychosis
- •Patients with Sepsis or Bacteremia.
- •Patients have lymphedema in acupuncture stimulation area.
- •Patients who are afraid of acupuncture stimulation or allergic to stainless steel needles can't participate in this study.
结局指标
主要结局
Change from Baseline in severity of nausea and vomiting at 21 days
时间窗: It will be assessed at baseline,day1, day 2, day 3, day 7(±1)，day 10(±1), day 14(±1), day 21(±1).Patients have a daily questionnaire about nausea and vomiting during chemotherapy to record their feelings
The severity of nausea and vomiting will be assessed by the Common Terminology Criteria for Adverse Events (CTCAE)
次要结局
- TCM symptoms scale(It will be assessed at baseline, day3, day7(±1), day14(±1), day21(±1).Patients will be accessed with questionaire by doctors.)
- ECOG score scale(It will be assessed at baseline, day3, day7(±1), day14(±1), day21(±1).Patients will be accessed with questionaire by doctors.)
- HADS(It will be assessed at baseline, day3, day7(±1), day14(±1), day21(±1).Patients will be accessed with questionaire by doctors.)
研究者
Wang Xiaomin
Doctor
Beijing Hospital of Traditional Chinese Medicine