Meng-Yue Liu1, Lai Sung2, Yan-Sen Liao2, Yi-Fei Jiao3, Chang-Sheng Sun1, Xiao-Dong Peng2. 1. Department of Traditional Chinese Medicine. 2. Oncology Department, Chengdu Second People's Hospital. 3. Department of Traditional Chinese Medicine, Chengdu Seventh People's Hospital, Chengdu, Sichuan Province, P.R. China.
Abstract
BACKGROUND: 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. METHODS: 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. DISCUSSION: This trial may provide evidence regarding the clinical effectiveness and safety of AA versus EA for CINV following cisplatin-based regimens. TRAIL REGISTRATION: This study is registered with the Chinese Clinical Trial Registry: ChiCTR2000040942.
BACKGROUND: 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. METHODS: 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. DISCUSSION: This trial may provide evidence regarding the clinical effectiveness and safety of AA versus EA for CINV following cisplatin-based regimens. TRAIL REGISTRATION: This study is registered with the Chinese Clinical Trial Registry: ChiCTR2000040942.
Authors: Jing-Yu Tan; Alexander Molassiotis; Tao Wang; Lorna K P Suen Journal: Evid Based Complement Alternat Med Date: 2014-11-25 Impact factor: 2.629