Chemotherapy-induced Nausea and VomitingACTINNCT02127255
Acupuncture for Chemical Therapy Induced Nausea and Vomiting: a Cross-over Trail
A study testing Manual acupuncture implemented by acupuncturist 1 and Manual acupuncture implemented by acupuncturist 2 in people with Chemotherapy-induced Nausea and Vomiting, run by Beijing University of Chinese Medicine at 1 site in China.
Trial summary
This is a randomized, controlled cross-over trial. The hypothesis of this study is that the differences in manual acupuncture manipulation can impact clinical effect though the acupuncturists follow the same needling regimen. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chemotherapy-induced Nausea and Vomiting
- What is being tested?
- Manual acupuncture implemented by acupuncturist 1 and Manual acupuncture implemented by acupuncturist 2
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteChina
- Study dates
- Apr 2014to Dec 2015
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of cancer
- Must receive cancer chemotherapy containing cisplatin
- Able to complete at least two continuous chemotherapy treatment cycles
- Karnofsky performance status grade ≥60
- Must 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
- Receiving radiotherapy
- Received acupuncture treatments for other conditions less than 4 weeks before chemotherapy treatment
- Severe infection
- Severe heart, liver, kidney and brain diseases
- Unconsciousness
Show all 10Show fewer
- Psychosis
- Language barriers
- Cardiac pacemaker
- Radiotherapy or hormone therapy during chemotherapy treatments
Trial locations and contacts
1 site in 1 country.
China1 site
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Beijing, 100091
About this study
This is a randomized, controlled cross-over trial. The hypothesis of this study is that the differences in manual acupuncture manipulation can impact clinical effect though the acupuncturists follow the same needling regimen. In this study, acupuncturist 1 (clinical experience >15 years) and acupuncturist 2 (<5 years) will give treatments to cancer patients receiving cisplatin chemotherapy (n=36) for at least two continuous cycles, once per day, 5 days per cycle. Acupuncturist 1 determines all the treatment regimens (selection of acupoints and methods of needling manipulation, needle retention time). Randomly, half of the patients will receive treatments from acupuncturist 1 in the first treatment cycle and from acupuncturist 2 in the second cycle; while the other half will be treated in other way round. There is a washout period (21 days) between two cycles. The needling manipulation of two acupuncturists will be measured objectively during treatments. The clinical effect will be measured by the control of vomiting and nausea during and after chemotherapy treatments.
Read the detailed description
This is a randomized, controlled cross-over trial. The hypothesis of this study is that the differences in manual acupuncture manipulation can impact clinical effect though the acupuncturists follow the same needling regimen. In this study, acupuncturist 1 (clinical experience >15 years) and acupuncturist 2 (<5 years) will give treatments to cancer patients receiving cisplatin chemotherapy (n=36) for at least two continuous cycles, once per day, 5 days per cycle. Acupuncturist 1 determines all the treatment regimens (selection of acupoints and methods of needling manipulation, needle retention time). Randomly, half of the patients will receive treatments from acupuncturist 1 in the first treatment cycle and from acupuncturist 2 in the second cycle; while the other half will be treated in other way round. There is a washout period (21 days) between two cycles. The needling manipulation of two acupuncturists will be measured objectively during treatments. The clinical effect will be measured by the control of vomiting and nausea during and after chemotherapy treatments. The manual manipulation of two acupuncturists will be recorded by device Acusensor.
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Being tested
- Manual acupuncture implemented by acupuncturist 1, Manual acupuncture implemented by acupuncturist 2
- Keywords
- chemotherapy, 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 acupuncturist 1Procedure or surgery
Also called Traditional manual acupuncture, Traditional acupuncture
Manual acupuncture once per day. Acupuncture treatment regimens (acupoints, needling methods, needle retention time) were decided by acupuncturist 1 according to the syndrome differentiation of patients. Acupuncturist 1 has to have more than 15 years of acupuncture clinical practice experience.
Manual acupuncture implemented by acupuncturist 2Procedure or surgery
Also called Traditional manual acupuncture, Traditional acupuncture
Manual acupuncture given by acupuncturist 2 once per day. Acupuncture treatment regimens (acupoints, needling methods, needle retention time) were decided by acupuncturist 1 according to the syndrome differentiation of patients. Acupuncturist 2 has to have less than 5 years of acupuncture clinical practice experience.
| Study group | Role | What they receive |
|---|---|---|
| A (Acupuncturist 1) | Active comparator | Manual acupuncture implemented by acupuncturist 1 (clinical experience >15 years) Receives: Procedure: Manual acupuncture implemented by acupuncturist 1 |
| B (Acupuncturist 2) | Active comparator | Manual acupuncture implemented by acupuncturist 2 (clinical experience < 5 years) Receives: Procedure: Manual acupuncture implemented by acupuncturist 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
NCI nausea and vomiting rating scale
Measured: day1-8 on each study period
Secondary outcomes (5)
Rhodes Scale
Measured: day1-5 on each study period
global assessment on effectiveness by patients (VAS)
Measured: day 5 on each study period
patients' confidence towards acupuncture treatment(VAS)
Measured: day 1,5 on each study period
global satisfaction for acupuncture treatments
Measured: day 5 on each study period
Acupuncture Expectancy Scale (AES)
Measured: day 1, 3, 5 on each study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2015
- Study completionDec 2015
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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Xiyuan Hospital of China Academy of Chinese Medical Sciences
- Responsible party
- Principal investigator, Yutong Fei, Beijing University of Chinese Medicine
- Investigators
- Yutong Fei, MD, Principal investigator, Beijing University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02127255
- Sponsor's protocol ID
- EBM@BUCM-1
- Other IDs
- Z111107054511086
- Acronym
- ACTIN
- Status last verified
- Apr 2016
- First submitted
- 29 Apr 2014
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Chemical Therapy Induced Nausea and Vomiting: a Cross-over Trail
- ClinicalTrials.gov ID
- NCT02127255
- Acronym / sponsor ID
- ACTIN / EBM@BUCM-1
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Keywords
- chemotherapy, nausea, vomiting, cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Beijing University of Chinese MedicineUniversity, hospital or other
- Collaborators
- Xiyuan Hospital of China Academy of Chinese Medical Sciences
- Study start
- Apr 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 30 Apr 2014 (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 a randomized, controlled cross-over trial. The hypothesis of this study is that the differences in manual acupuncture manipulation can impact clinical effect though the acupuncturists follow the same needling regimen. In this study, acupuncturist 1 (clinical experience >15 years) and acupuncturist 2 (<5 years) will give treatments to cancer patients receiving cisplatin chemotherapy (n=36) for at least two continuous cycles, once per day, 5 days per cycle. Acupuncturist 1 determines all the treatment regimens (selection of acupoints and methods of needling manipulation, needle retention time). Randomly, half of the patients will receive treatments from acupuncturist 1 in the first treatment cycle and from acupuncturist 2 in the second cycle; while the other half will be treated in other way round. There is a washout period (21 days) between two cycles. The needling manipulation of two acupuncturists will be measured objectively during treatments. The clinical effect will be measured by the control of vomiting and nausea during and after chemotherapy treatments.
Detailed description
This is a randomized, controlled cross-over trial. The hypothesis of this study is that the differences in manual acupuncture manipulation can impact clinical effect though the acupuncturists follow the same needling regimen. In this study, acupuncturist 1 (clinical experience >15 years) and acupuncturist 2 (<5 years) will give treatments to cancer patients receiving cisplatin chemotherapy (n=36) for at least two continuous cycles, once per day, 5 days per cycle. Acupuncturist 1 determines all the treatment regimens (selection of acupoints and methods of needling manipulation, needle retention time). Randomly, half of the patients will receive treatments from acupuncturist 1 in the first treatment cycle and from acupuncturist 2 in the second cycle; while the other half will be treated in other way round. There is a washout period (21 days) between two cycles. The needling manipulation of two acupuncturists will be measured objectively during treatments. The clinical effect will be measured by the control of vomiting and nausea during and after chemotherapy treatments. The manual manipulation of two acupuncturists will be recorded by device Acusensor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A (Acupuncturist 1) | Active comparator | Procedure: Manual acupuncture implemented by acupuncturist 1Manual acupuncture implemented by acupuncturist 1 (clinical experience >15 years) |
| B (Acupuncturist 2) | Active comparator | Procedure: Manual acupuncture implemented by acupuncturist 2Manual acupuncture implemented by acupuncturist 2 (clinical experience < 5 years) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed diagnosis of cancer
- Must receive cancer chemotherapy containing cisplatin
- Able to complete at least two continuous chemotherapy treatment cycles
- Karnofsky performance status grade ≥60
- Must use 5-TH receptor antagonists as an antiemetic drug in the chemotherapy duration
Key exclusion criteria (10 listed)
- Concurrent neoplasms or illness that induces nausea independent of chemotherapy
- Receiving radiotherapy
- Received acupuncture treatments for other conditions less than 4 weeks before chemotherapy treatment
- Severe infection
- Severe heart, liver, kidney and brain diseases
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 acupuncturist 1Also: Traditional manual acupuncture, Traditional acupunctureManual acupuncture once per day. Acupuncture treatment regimens (acupoints, needling methods, needle retention time) were decided by acupuncturist 1 according to the syndrome differentiation of patients. Acupuncturist 1 has to have more than 15 years of acupuncture clinical practice experience. | Procedure or surgery | A (Acupuncturist 1) |
| Manual acupuncture implemented by acupuncturist 2Also: Traditional manual acupuncture, Traditional acupunctureManual acupuncture given by acupuncturist 2 once per day. Acupuncture treatment regimens (acupoints, needling methods, needle retention time) were decided by acupuncturist 1 according to the syndrome differentiation of patients. Acupuncturist 2 has to have less than 5 years of acupuncture clinical practice experience. | Procedure or surgery | B (Acupuncturist 2) |
Primary outcome
NCI nausea and vomiting rating scale
Time frame: day1-8 on each study period
5 secondary outcomes
Rhodes Scale
Time frame: day1-5 on each study period
global assessment on effectiveness by patients (VAS)
Time frame: day 5 on each study period
patients' confidence towards acupuncture treatment(VAS)
Time frame: day 1,5 on each study period
global satisfaction for acupuncture treatments
Time frame: day 5 on each study period
Acupuncture Expectancy Scale (AES)
Time frame: day 1, 3, 5 on each study period
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 15 Apr 2016.
- Individual participant dataSharing planned: Undecided
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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.
Yutong Fei, MD principal investigator
Beijing University of Chinese Medicine
1 site 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 acupuncturist 1 and Manual acupuncture implemented by acupuncturist 2 in people with Chemotherapy-induced Nausea and Vomiting, run by Beijing University of Chinese Medicine at 1 site 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 5 inclusion and 10 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 15 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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: day1-8 on each study period). 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 15 Apr 2016.