Transcutaneous Electrical Acupoint Stimulation Ameliorates Chemotherapy-Induced Bone Marrow Suppression in Lung Cancer Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Change of Blood routine indexes in 1 month
研究概览
简要总结
To investigate the effect of percutaneous electrical stimulation on chemotherapy-induced bone marrow suppression in patients with lung cancer.
详细描述
Lung cancer is the malignant neoplasm with the highest incidence and mortality in China as well as worldwide. Non-small cell lung cancer (NSCLC) accounts for 80%-85% of all lung cancer cases. Chemotherapy is the preferred treatment method for NSCLC, but many patients cannot tolerate the adverse reactions of chemotherapy. Among the most common and most severe adverse reactions is bone marrow suppression. The more serious the bone marrow suppression, the higher the direct medical cost of chemotherapy. Literatures showed Acupuncture was used to treat patients with chemotherapy-induced bone marrow suppression. In this study, the effect of percutaneous electrical stimulation of acupoints including Dazhui (DU14), Geshu (BL17), Zusanli (ST36), Sanyinjiao (SP6), and Hegu (LI4) will be investigated, compared with the medication group treated by oral administration of prophylactic agents, and the control group received routine nursing care on chemotherapy-induced bone marrow suppression in patients with lung cancer.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of Non-small cell lung cancer(NSCLC)
- •age between 20 and 75 years
- •chemotherapy naive after diagnosis
- •GP regimen as treatment
- •an expected survival of more than 12 weeks based on a score equal to or greater than 60 points on Karnofsky performance status (KPS) scale
- •the ability to understand and speak Mandarin
排除标准
- •diagnosis of a hematological system tumor
- •mental illness
- •bone marrow suppression prior to chemotherapy
- •pregnancy
研究组 & 干预措施
TEAS group
Patients with transcutaneous electrical acupoint stimulation (TEAS) group receive electrical stimulation of acupoints including Dazhui (DU14), Geshu (BL17), Zusanli (ST36), Sanyinjiao (SP6), and Hegu (LI4).
干预措施: TEAS (Device)
Medication group
On the basis of routine nursing care, patients need to take Sanguisorba officinalis L., named Diyu Shengbai Pian (a Traditional Chinese Medicine) 3 times per day.
干预措施: Sanguisorba officinalis L. (Drug)
结局指标
主要结局
Change of Blood routine indexes in 1 month
时间窗: Day 0, Day 5, Day 8, Day 11, Day 14, Day 21 and Day 28
The routine blood examinations of indicators of bone marrow suppression, including red blood cells (10\^12/L), hemoglobin (g/L), white blood cells (10\^9/L), and platelets (10\^9/L).
次要结局
- Change of Comfort Degree(Day 0, Day 8, and Day 28)
研究者
Caicun Zhou
Director
Tongji University