Chemotherapy-induced Nausea and VomitingNCT02842307
Acupuncture for Chemical Therapy Induced Nausea and Vomiting
A study testing Manual acupuncture implemented by senior acupuncturists, Manual acupuncture implemented by junior acupuncturists and Manual acupuncture on P6 point in people with Chemotherapy-induced Nausea and Vomiting, run by Beijing University of Chinese Medicine at 3 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Nausea and Vomiting
- What is being tested?
- Manual acupuncture implemented by senior acupuncturists, Manual acupuncture implemented by junior acupuncturists and Manual acupuncture on P6 point
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 3 sitesChina
- Study dates
- Jan 2010to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of cancer
- Must receive cancer chemotherapy containing cisplatin
- Use 5-TH receptor antagonists as an antiemetic drug in the chemotherapy duration
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
China3 sites
Dongzhimen Hospital, Beijing University of Chinese medicine
Beijing, Beijing Municipality, 100007
Guanganmen Hospital,China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100053
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Beijing, 100091
About this study
Official title: Impact of Acupuncturist Expertise on Clinical Effectiveness for Chemotherapy Induced Nausea and Vomiting in Cancer Patients: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Being tested
- Manual acupuncture implemented by senior acupuncturists, Manual acupuncture implemented by junior acupuncturists, Manual acupuncture on P6 point
- Keywords
- Acupuncture, Expertise-based randomized controlled trial, Nausea, Vomiting, Cancer
- Medical subject headings
- Vomiting, Nausea, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual acupuncture implemented by senior acupuncturistsProcedure or surgery
Also called Traditional manual acupuncture, Traditional acupuncture
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 implemented by junior acupuncturistsProcedure or surgery
Also called Traditional manual acupuncture, Traditional acupuncture
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 on P6 pointProcedure or surgery
Also called Traditional manual acupuncture, Traditional acupuncture
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.
| Study group | Role | What they receive |
|---|---|---|
| A(senior acupuncturists) | Active comparator | Manual acupuncture implemented by senior acupuncturists (clinical experience >15 years) Receives: Procedure: Manual acupuncture implemented by senior acupuncturists |
| B(junior acupuncturists) | Active comparator | Manual acupuncture implemented by junior acupuncturists (clinical experience <5 years) Receives: Procedure: Manual acupuncture implemented by junior acupuncturists |
| C(P6 points) | Active comparator | Manual acupuncture on P6 points by junior acupuncturists (clinical experience <5 years) Receives: Procedure: Manual acupuncture on P6 point |
| D(no acupuncture) | No intervention | No acupuncture treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
NCI nausea and vomiting rating scale
Measured: From the first day receiving cisplatin until two days after cisplatin in each group
Rhodes Scale
Measured: 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)
Measured: The second day after cisplatin
Patients' confidence towards acupuncture treatment (a single direct question with five levels of alternatives)
Measured: The first day receiving cisplatin and the second day after cisplatin
Consumption of additional antiemetic
Measured: From the first day receiving cisplatin until two days after cisplatin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study startJan 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Nausea and VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Dongzhimen Hospital, Beijing, Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Xiyuan Hospital of China Academy of Chinese Medical Sciences
- Responsible party
- Principal investigator, Yutong Fei, Beijing University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02842307
- Sponsor's protocol ID
- EBM@BUCM-2
- Other IDs
- 30901929
- Status last verified
- Jul 2016
- First submitted
- 16 Jul 2016
- Last updated
- 22 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Acupuncturist Expertise on Clinical Effectiveness for Chemotherapy Induced Nausea and Vomiting in Cancer Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02842307
- Acronym / sponsor ID
- EBM@BUCM-2
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Keywords
- Acupuncture, Expertise-based randomized controlled trial, Nausea, Vomiting, Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Beijing University of Chinese MedicineUniversity, hospital or other
- Collaborators
- Dongzhimen Hospital, Beijing, Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Xiyuan Hospital of China Academy of Chinese Medical Sciences
- Study start
- Jan 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 22 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A(senior acupuncturists) | Active comparator | Procedure: Manual acupuncture implemented by senior acupuncturistsManual acupuncture implemented by senior acupuncturists (clinical experience >15 years) |
| B(junior acupuncturists) | Active comparator | Procedure: Manual acupuncture implemented by junior acupuncturistsManual acupuncture implemented by junior acupuncturists (clinical experience <5 years) |
| C(P6 points) | Active comparator | Procedure: Manual acupuncture on P6 pointManual acupuncture on P6 points by junior acupuncturists (clinical experience <5 years) |
| D(no acupuncture) | No intervention | –No acupuncture treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmed diagnosis of cancer
- Must receive cancer chemotherapy containing cisplatin
- Use 5-TH receptor antagonists as an antiemetic drug in the chemotherapy duration
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual acupuncture implemented by senior acupuncturistsAlso: Traditional manual acupuncture, Traditional acupunctureManual 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. | Procedure or surgery | A(senior acupuncturists) |
| Manual acupuncture implemented by junior acupuncturistsAlso: Traditional manual acupuncture, Traditional acupunctureManual 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. | Procedure or surgery | B(junior acupuncturists) |
| Manual acupuncture on P6 pointAlso: Traditional manual acupuncture, Traditional acupunctureManual 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. | Procedure or surgery | C(P6 points) |
Primary outcome
NCI nausea and vomiting rating scale
Time frame: From the first day receiving cisplatin until two days after cisplatin in each group
Rhodes Scale
Time frame: From the first day receiving cisplatin until two days after cisplatin in each group
3 secondary outcomes
Global assessment on effectiveness by patients (a single direct question with five levels of alternatives)
Time frame: The second day after cisplatin
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
Consumption of additional antiemetic
Time frame: From the first day receiving cisplatin until two days after cisplatin
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual acupuncture implemented by senior acupuncturists, Manual acupuncture implemented by junior acupuncturists and Manual acupuncture on P6 point in people with Chemotherapy-induced Nausea and Vomiting, run by Beijing University of Chinese Medicine at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NCI nausea and vomiting rating scale (time frame: From the first day receiving cisplatin until two days after cisplatin in each group). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2016.