Acupuncture for Chemical Therapy Induced Nausea and Vomiting

Not Applicable

Completed

• Conditions: Chemotherapy-induced Nausea and Vomiting
• Interventions: Procedure: Manual acupuncture implemented by senior acupuncturists; Procedure: Manual acupuncture on P6 point; Procedure: Manual acupuncture implemented by junior acupuncturists

• Registration Number: NCT02842307
• Lead Sponsor: Beijing University of Chinese Medicine

Brief 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.

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2016-07
• Study First Submitted: 2016-07-16
• Study First Submitted QC: 2016-07-20
• Last Update Submitted: 2016-07-20
• Study First Posted: 2016-07-22
• Last Update Posted: 2016-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A(senior acupuncturists)	Manual acupuncture implemented by senior acupuncturists	Manual acupuncture implemented by senior acupuncturists (clinical experience \>15 years)
C(P6 points)	Manual acupuncture on P6 point	Manual acupuncture on P6 points by junior acupuncturists (clinical experience \<5 years)
B(junior acupuncturists)	Manual acupuncture implemented by junior acupuncturists	Manual acupuncture implemented by junior acupuncturists (clinical experience \<5 years)

Primary Outcome Measures

Name	Time	Method
NCI nausea and vomiting rating scale	From the first day receiving cisplatin until two days after cisplatin in each group
Rhodes Scale	From the first day receiving cisplatin until two days after cisplatin in each group

Secondary Outcome Measures

Name	Time	Method
Global assessment on effectiveness by patients (a single direct question with five levels of alternatives)	The second day after cisplatin
Patients' confidence towards acupuncture treatment (a single direct question with five levels of alternatives)	The first day receiving cisplatin and the second day after cisplatin
Consumption of additional antiemetic	From the first day receiving cisplatin until two days after cisplatin

Trial Locations

Locations (3)

Dongzhimen Hospital, Beijing University of Chinese medicine; 🇨🇳 Beijing, Beijing, China

Guanganmen Hospital,China Academy of Chinese Medical Sciences; 🇨🇳 Beijing, Beijing, China

Xiyuan Hospital, China Academy of Chinese Medical Sciences; 🇨🇳 Beijing, China