Acupuncture for Chemical Therapy Induced Nausea and Vomiting

Impact of Acupuncturist Expertise on Clinical Effectiveness for Chemotherapy Induced Nausea and Vomiting in Cancer Patients: a Randomized Controlled Trial

Dongzhimen Hospital, Beijing, Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Xiyuan Hospital of China Academy of Chinese Medical Sciences

This is an expertise-based randomized controlled trial. The hypothesis of this study is that the differences in expertise of acupuncturist may impact clinical effect. In this study, patients will be randomized to 4 group, receiving the treatment from senior acupuncturist, junior acupuncturist, junior acupuncturist by only acupuncture Neiguan(P6), or not receive the acupuncture. All patients receive the basic cisplatin chemotherapy. The duration of treatment is from the first day receiving cisplatin until two days after cisplatin on each group. NCI and Rhode scale will be used to measure the control of nausea and vomiting.

This is an expertise-based randomized controlled trial. The hypothesis of this study is that the differences in expertise of acupuncturist may impact clinical effect. In this study, 102 patients will be randomly divided into 4 groups which separately receiving the treatment from senior acupuncturist(clinical experience> 15 years, considered in this trial as highly expertised), junior acupuncturist(clinical experience< 5 years, considered in this trial as lower expertised), junior acupuncturist only acupuncture Neiguan(P6), or not receiving the acupuncture. All participants receive the cisplatin-based chemotherapy and 5-HT3 as antiemetic treatment will be included. Acupuncture treatments are given once daily, the duration of treatment is from the first day receiving cisplatin until two days after cisplatin. NCI and Rhode scale will be used to measure the control of nausea and vomiting. only outcome assessors are blinded. Generalized estimating equations will be used to compare the effects among groups.

Manual acupuncture once per day. No limitation on points, manipulations and time per session. Senior acupuncturists have to have more than 15 years of acupuncture clinical practice experience.

Manual acupuncture once per day. No limitation on points, manipulations and time per session. Junior acupuncturists have to have less than 5 years of acupuncture clinical practice experience.

Manual acupuncture implemented by junior acupuncturists once per day. P6 point, bilaterally, should achieve deqi sensation by even manipulations. Junior acupuncturists have to have less than 5 years of acupuncture clinical practice experience.

Global assessment on effectiveness by patients (a single direct question with five levels of alternatives)

Patients' confidence towards acupuncture treatment (a single direct question with five levels of alternatives)

Inclusion Criteria: Confirmed diagnosis of cancer Must receive cancer chemotherapy containing cisplatin Use 5-TH receptor antagonists as an antiemetic drug in the chemotherapy duration Exclusion Criteria: Concurrent neoplasms or illness that induces nausea independent of chemotherapy Received acupuncture treatments for other conditions less than 4 weeks before chemotherapy treatment Severe infection Severe heart, liver, kidney and brain diseases Cardiac pacemaker Radiotherapy or hormone therapy during chemotherapy treatments