Department of Traditional Chinese Medicine.
Oncology Department, Chengdu Second People's Hospital.
Medicine (Baltimore). 2021 Feb 19;100(7):e24588. doi: 10.1097/MD.0000000000024588.
Nausea and vomiting are among the most common and distressing side effects of chemotherapy. Difference in views about the effectiveness of auricular acupuncture (AA) versus electroacupuncture (EA) of chemotherapy-induced nausea and vomiting (CINV) lies at the heart of the debate. The aim of this study is to compare the antiemetic efficacy and safety of AA and EA for CINV.
One hundred twenty participants, 18 to 75 years old malignant tumors will receiving chemotherapy with cisplatin, will be recruited and randomized into 3 groups equally, Group A (the AA group), Group B (the EA group), and Group C (the control group). The participants in Group A and Group B will receive AA or EA regimens, alternatively, beginning on the day before first day of chemotherapy for a third consecutive cycles. All participants will continue to receive conventional treatment. The incidence and severity of CINV will be assessed using the definition and classification of nausea and vomiting (NCI-CTC AE4.0) and the MASCC (Multinational Association for Supportive Care in Cancer) Antiemesis Tool (MAT). Secondary outcome measures include the degree of abdominal distension, the first time of flatus and defecation, and life quality. Additionally, adverse events will also be documented during the period of the treatment.
This trial may provide evidence regarding the clinical effectiveness and safety of AA versus EA for CINV following cisplatin-based regimens.
This study is registered with the Chinese Clinical Trial Registry: ChiCTR2000040942.
恶心和呕吐是化疗最常见和最令人痛苦的副作用之一。对耳针(AA)与电针(EA)治疗化疗引起的恶心和呕吐(CINV)疗效的看法存在差异,这是争论的核心。本研究旨在比较 AA 和 EA 治疗 CINV 的止吐效果和安全性。
将招募 120 名年龄在 18 至 75 岁之间、接受顺铂化疗的恶性肿瘤患者,并将其随机分为 3 组,每组 40 人,分别为 A 组(AA 组)、B 组(EA 组)和 C 组(对照组)。A 组和 B 组的患者将在化疗前一天开始接受 AA 或 EA 治疗,连续 3 个周期。所有患者将继续接受常规治疗。采用恶心和呕吐的定义和分类(NCI-CTC AE4.0)和 MASCC(癌症支持治疗多国协会)止吐工具(MAT)评估 CINV 的发生率和严重程度。次要终点包括腹胀程度、首次排气和排便时间以及生活质量。此外,在治疗期间还将记录不良反应事件。
该试验可能为基于顺铂方案的 AA 与 EA 治疗 CINV 的临床疗效和安全性提供证据。
本研究在中国临床试验注册中心注册:ChiCTR2000040942。