Acupuncture for Chemical Therapy Induced Nausea and Vomiting
Impact of Acupuncturist Expertise on Clinical Effectiveness for Chemotherapy Induced Nausea and Vomiting in Cancer Patients: a Randomized Controlled Trial
2 other identifiers
interventional
102
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2010
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 16, 2016
CompletedFirst Posted
Study publicly available on registry
July 22, 2016
CompletedJuly 22, 2016
July 1, 2016
2.9 years
July 16, 2016
July 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
NCI nausea and vomiting rating scale
From the first day receiving cisplatin until two days after cisplatin in each group
Rhodes Scale
From the first day receiving cisplatin until two days after cisplatin in each group
Secondary Outcomes (3)
Global assessment on effectiveness by patients (a single direct question with five levels of alternatives)
The second day after cisplatin
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
Consumption of additional antiemetic
From the first day receiving cisplatin until two days after cisplatin
Other Outcomes (2)
Acupuncture related adverse events
From the first day receiving cisplatin until two days after cisplatin
Adverse events
From the first day receiving cisplatin until two days after cisplatin
Study Arms (4)
A(senior acupuncturists)
ACTIVE COMPARATORManual acupuncture implemented by senior acupuncturists (clinical experience \>15 years)
B(junior acupuncturists)
ACTIVE COMPARATORManual acupuncture implemented by junior acupuncturists (clinical experience \<5 years)
C(P6 points)
ACTIVE COMPARATORManual acupuncture on P6 points by junior acupuncturists (clinical experience \<5 years)
D(no acupuncture)
NO INTERVENTIONNo acupuncture treatment
Interventions
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 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 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.
Eligibility Criteria
You may qualify if:
- Confirmed diagnosis of cancer
- Must receive cancer chemotherapy containing cisplatin
- Use 5-TH receptor antagonists as an antiemetic drug in the chemotherapy duration
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Dongzhimen Hospital, Beijing University of Chinese medicine
Beijing, Beijing Municipality, 100007, China
Guanganmen Hospital,China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100053, China
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Beijing, 100091, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate research fellow
Study Record Dates
First Submitted
July 16, 2016
First Posted
July 22, 2016
Study Start
January 1, 2010
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
July 22, 2016
Record last verified: 2016-07