Acupuncture for Chemical Therapy Induced Nausea and Vomiting

Chemotherapy-induced Nausea and Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02842307
• Other study ID #: EBM@BUCM-2
• Secondary ID: 30901929
• Status: Completed
• Phase: N/A
• First received: July 16, 2016
• Last updated: July 20, 2016
• Start date: January 2010
• Est. completion date: December 2012

Study information

• Verified date: July 2016
• Source: Beijing University of Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chemotherapy-induced Nausea and Vomiting
• Nausea
• Vomiting

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
China	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

Sponsors (4)

Lead Sponsor	Collaborator
Beijing University of Chinese Medicine	Dongzhimen Hospital, Beijing, Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Xiyuan Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acupuncture related adverse events		From the first day receiving cisplatin until two days after cisplatin	Yes
Other	Adverse events		From the first day receiving cisplatin until two days after cisplatin	Yes
Primary	NCI nausea and vomiting rating scale		From the first day receiving cisplatin until two days after cisplatin in each group	No
Primary	Rhodes Scale		From the first day receiving cisplatin until two days after cisplatin in each group	No
Secondary	Global assessment on effectiveness by patients (a single direct question with five levels of alternatives)		The second day after cisplatin	No
Secondary	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	No
Secondary	Consumption of additional antiemetic		From the first day receiving cisplatin until two days after cisplatin	No