Acupuncture for Chemical Therapy Induced Nausea and Vomiting

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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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

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Chemotherapy-induced Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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A(senior acupuncturists)

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

Group Type ACTIVE_COMPARATOR

Manual acupuncture implemented by senior acupuncturists

Intervention Type PROCEDURE

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.

B(junior acupuncturists)

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

Group Type ACTIVE_COMPARATOR

Manual acupuncture implemented by junior acupuncturists

Intervention Type PROCEDURE

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.

C(P6 points)

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

Group Type ACTIVE_COMPARATOR

Manual acupuncture on P6 point

Intervention Type PROCEDURE

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.

D(no acupuncture)

No acupuncture treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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Traditional manual acupuncture Traditional acupuncture Traditional manual acupuncture Traditional acupuncture Traditional manual acupuncture Traditional acupuncture

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No