NCT02842307

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Beijing University of Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Chemotherapy-induced Nausea and Vomiting

Interventions

Type	Name	Description
PROCEDURE	Manual acupuncture implemented by senior acupuncturists	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.
PROCEDURE	Manual acupuncture implemented by junior acupuncturists	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.
PROCEDURE	Manual acupuncture on P6 point	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.

Timeline

• Start date: 2010-01-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2016-07-22
• Last updated: 2016-07-22

Locations

3 sites across 1 country: China