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Acupuncture for Chemical Therapy Induced Nausea and Vomiting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02842307
Recruitment Status : Completed
First Posted : July 22, 2016
Last Update Posted : July 22, 2016
Sponsor:
Collaborators:
Dongzhimen Hospital, Beijing
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Information provided by (Responsible Party):
Yutong Fei, Beijing University of Chinese Medicine

Brief 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.

Condition or disease Intervention/treatment Phase
Chemotherapy-induced Nausea and Vomiting Procedure: Manual acupuncture implemented by senior acupuncturists Procedure: Manual acupuncture implemented by junior acupuncturists Procedure: Manual acupuncture on P6 point Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Acupuncturist Expertise on Clinical Effectiveness for Chemotherapy Induced Nausea and Vomiting in Cancer Patients: a Randomized Controlled Trial
Study Start Date : January 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02842307


Locations
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China, Beijing
Dongzhimen Hospital, Beijing University of Chinese medicine
Beijing, Beijing, China, 100007
Guanganmen Hospital,China Academy of Chinese Medical Sciences
Beijing, Beijing, China, 100053
China
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Beijing, China, 100091
Sponsors and Collaborators
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
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Responsible Party: Yutong Fei, Associate research fellow, Beijing University of Chinese Medicine
ClinicalTrials.gov Identifier: NCT02842307    
Other Study ID Numbers: EBM@BUCM-2
30901929 ( Other Grant/Funding Number: National Natural Science )
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: July 22, 2016
Last Verified: July 2016
Keywords provided by Yutong Fei, Beijing University of Chinese Medicine:
Acupuncture
Expertise-based randomized controlled trial
Nausea
Vomiting
Cancer
Additional relevant MeSH terms:
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Nausea
Vomiting
Signs and Symptoms, Digestive