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

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.

Study Overview

• Status: Completed
• Conditions: Chemotherapy-induced Nausea and Vomiting
• Intervention / Treatment: Procedure: Manual acupuncture implemented by senior acupuncturists; Procedure: Manual acupuncture implemented by junior acupuncturists; Procedure: Manual acupuncture on P6 point

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 Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100091
    • Xiyuan Hospital, China Academy of Chinese Medical Sciences
  • Beijing
    • Beijing, Beijing, China, 100007
      • Dongzhimen Hospital, Beijing University of Chinese Medicine
    • Beijing, Beijing, China, 100053
      • Guanganmen Hospital,China Academy of Chinese Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A(senior acupuncturists); Manual acupuncture implemented by senior acupuncturists (clinical experience >15 years)	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.; Other Names: Traditional manual acupuncture; Traditional acupuncture
Active Comparator: B(junior acupuncturists); Manual acupuncture implemented by junior acupuncturists (clinical experience <5 years)	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.; Other Names: Traditional manual acupuncture; Traditional acupuncture
Active Comparator: C(P6 points); Manual acupuncture on P6 points by junior acupuncturists (clinical experience <5 years)	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.; Other Names: Traditional manual acupuncture; Traditional acupuncture
No Intervention: D(no acupuncture); No acupuncture treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Other Outcome Measures

Outcome Measure	Time Frame
Acupuncture related adverse events	From the first day receiving cisplatin until two days after cisplatin
Adverse events	From the first day receiving cisplatin until two days after cisplatin

Collaborators and Investigators

• Sponsor: Beijing University of Chinese Medicine
• Collaborators: Guang'anmen Hospital of China Academy of Chinese Medical Sciences; Xiyuan Hospital of China Academy of Chinese Medical Sciences; Dongzhimen Hospital, Beijing

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: July 16, 2016
• First Submitted That Met QC Criteria: July 20, 2016
• First Posted (Estimate): July 22, 2016

Study Record Updates

• Last Update Posted (Estimate): July 22, 2016
• Last Update Submitted That Met QC Criteria: July 20, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Cancer; Acupuncture; Nausea; Vomiting; Expertise-based randomized controlled trial
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Nausea; Vomiting
• Other Study ID Numbers: EBM@BUCM-2; 30901929 (Other Grant/Funding Number: National Natural Science)