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NCT Number: NCT02842307

Acupuncture for Chemical Therapy Induced Nausea and Vomiting

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dongzhimen Hospital, Beijing University of Chinese medicine, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Manual acupuncture implemented by senior acupuncturists

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.

Other names: Traditional manual acupuncture, Traditional acupuncture

Manual acupuncture implemented by junior acupuncturists

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.

Other names: Traditional manual acupuncture, Traditional acupuncture

Manual acupuncture on P6 point

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.

Other names: Traditional manual acupuncture, Traditional acupuncture

Primary outcomes

  1. NCI nausea and vomiting rating scale

    Time frame: From the first day receiving cisplatin until two days after cisplatin in each group

  2. Rhodes Scale

    Time frame: From the first day receiving cisplatin until two days after cisplatin in each group

Secondary outcomes

  1. Global assessment on effectiveness by patients (a single direct question with five levels of alternatives)

    Time frame: The second day after cisplatin

  2. Patients' confidence towards acupuncture treatment (a single direct question with five levels of alternatives)

    Time frame: The first day receiving cisplatin and the second day after cisplatin

  3. Consumption of additional antiemetic

    Time frame: From the first day receiving cisplatin until two days after cisplatin

Other outcomes

  1. Acupuncture related adverse events

    Time frame: From the first day receiving cisplatin until two days after cisplatin

  2. Adverse events

    Time frame: From the first day receiving cisplatin until two days after cisplatin

Sponsors and collaborators

Lead sponsor

Beijing University of Chinese Medicine

Other

Collaborators

  • Dongzhimen Hospital, Beijing
  • Guang'anmen Hospital of China Academy of Chinese Medical Sciences
  • Xiyuan Hospital of China Academy of Chinese Medical Sciences

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jul 22, 2016
Registry last updated
Jul 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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