Acupuncture for Chemical Therapy Induced Nausea and Vomiting

Beijing University of Chinese Medicine

Status: Completed

Conditions: Chemotherapy-induced Nausea and Vomiting

Treatments: Procedure: Manual acupuncture implemented by senior acupuncturists; Procedure: Manual acupuncture implemented by junior acupuncturists; Procedure: Manual acupuncture on P6 point

Study type: Interventional

Funder types: Other

Identifiers

NCT02842307

30901929 (Other Grant/Funding Number)

EBM@BUCM-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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102 participants in 4 patient groups

A(senior acupuncturists)

Active Comparator group

Description:

Manual acupuncture implemented by senior acupuncturists (clinical experience \>15 years)

Treatment:

Procedure: Manual acupuncture implemented by senior acupuncturists

B(junior acupuncturists)

Active Comparator group

Description:

Manual acupuncture implemented by junior acupuncturists (clinical experience \<5 years)

Treatment:

Procedure: Manual acupuncture implemented by junior acupuncturists

C(P6 points)

Active Comparator group

Description:

Manual acupuncture on P6 points by junior acupuncturists (clinical experience \<5 years)

Treatment:

Procedure: Manual acupuncture on P6 point

D(no acupuncture)

No Intervention group

Description:

No acupuncture treatment