Lung NeoplasmsNCT02469493
The Effect and Mechanism of Electroacupuncture on Acute Chemotherapy-induced Nausea and Vomiting
A study testing acupuncture (Huatuo) in people with Lung Neoplasms, run by Xidian University at 1 site in China.
Trial summary
The purpose of this study is to compare the preventive effect of electroacupuncture and sham acupuncture on acute chemotherapy-induced nausea and vomiting and then investigate its potential mechanism by using functional Magnetic Resonance Imaging (fMRI). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- acupuncture (Huatuo)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Jul 2017
- 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
- First diagnosed stage Ⅲ-Ⅳ lung cancer patients on cisplatin chemotherapy;
- Right-handed and aged 18 to 75 years;
- Karnosky performance status (KPS) ≥ 70;
- Life expectancy ≥ 6 months.
Who cannot join
- Had brain metastases or other concurrent life-threatening diseases;
- Nausea and/or vomiting were present 24h before chemotherapy treatment;
- Suffered from or had a history of gastrointestinal diseases;
- Had a history of head trauma, serious neurological or psychiatric disorders;
- Participating in other clinical trials currently;
- Had any contraindication to exposure to a high magnetic field or receive acupuncture
Trial locations and contacts
1 site in 1 country.
Jin, Doctor contact
China1 site, 1 recruiting
- Recruiting
Xijing Hospital
Xi'an, Shaanxi, 710032
Yang, 86(029)-84775343
About this study
The purpose of this study is to compare the preventive effect of electroacupuncture and sham acupuncture on acute chemotherapy-induced nausea and vomiting and then investigate its potential mechanism by using functional Magnetic Resonance Imaging (fMRI).
- Conditions
- Lung Neoplasms
- Being tested
- acupuncture (Huatuo)
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupuncture (Huatuo)Device
The needles used were Huatuo brand (Suzhou, China) sterile disposable stainless steel filiform; needles sized 0.25*25 mm. After disinfection, needles were inserted 0.5 to 0.8 inches into the skin and were manipulated manually to obtain Deqi. An electric stimulator (Huatuo SDZ-V, Suzhou, China) was connected to the needles and delivered a constant-current, 0.2-ms, density-wave, stimulus of 2 to 10-Hz frequency, level of intensity was as much as tolerable, but not painful to the subjects. The needles were left for 30 minutes and then removed.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture 1 | Experimental | In this group, patients separately received twice electroacupuncture at bilateral PC6 acupoint before and after Cisplatin administration on the first day of chemotherapy. Receives: Device: acupuncture (Huatuo) |
| Acupuncture 2 | Experimental | In this group, patients separately received twice electroacupuncture at bilateral PC6 and RN12 acupoints before and after Cisplatin administration on the first day of chemotherapy. Receives: Device: acupuncture (Huatuo) |
| Sham acupuncture | Sham comparator | In this group, patients separately received twice electroacupuncture at bilateral nonacupuncture point (S1 located at lateral of flexor carpi radialis, 2 cun above the wrist. S2 located at 3 cun right side of RN12) before and after Cisplatin administration on the first day of chemotherapy. Receives: Device: acupuncture (Huatuo) |
| Waitinglist control | No intervention | In this group, patients received no electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
The scores of Rhodes Index of Nausea, Vomiting and Retching.
Measured: 24 hours
Secondary outcomes (4)
Content of 5-hiaa in urine
Measured: 12 hours
Heart Rate Variability
Measured: 1 hour
Tachygastria percentage
Measured: 1 hour
Dosage of antiemetic drugs
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2015 (estimated)
- Study startJan 2015
- Primary completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xidian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Qin, Xidian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02469493
- Sponsor's protocol ID
- 2014CB543203
- Status last verified
- Jun 2015
- First submitted
- 8 Jun 2015
- Last updated
- 22 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect and Mechanism of Electroacupuncture on Acute Chemotherapy-induced Nausea and Vomiting
- ClinicalTrials.gov ID
- NCT02469493
- Acronym / sponsor ID
- 2014CB543203
- Conditions
- Lung Neoplasms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Xidian UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jul 2017 (estimated)
- First posted
- 11 Jun 2015 (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.
The purpose of this study is to compare the preventive effect of electroacupuncture and sham acupuncture on acute chemotherapy-induced nausea and vomiting and then investigate its potential mechanism by using functional Magnetic Resonance Imaging (fMRI).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Acupuncture 1 | Experimental | Device: acupuncture (Huatuo)In this group, patients separately received twice electroacupuncture at bilateral PC6 acupoint before and after Cisplatin administration on the first day of chemotherapy. |
| Acupuncture 2 | Experimental | Device: acupuncture (Huatuo)In this group, patients separately received twice electroacupuncture at bilateral PC6 and RN12 acupoints before and after Cisplatin administration on the first day of chemotherapy. |
| Sham acupuncture | Sham comparator | Device: acupuncture (Huatuo)In this group, patients separately received twice electroacupuncture at bilateral nonacupuncture point (S1 located at lateral of flexor carpi radialis, 2 cun above the wrist. S2 located at 3 cun right side of RN12) before and after Cisplatin administration on the first day of chemotherapy. |
| Waitinglist control | No intervention | –In this group, patients received no electroacupuncture |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- First diagnosed stage Ⅲ-Ⅳ lung cancer patients on cisplatin chemotherapy;
- Right-handed and aged 18 to 75 years;
- Karnosky performance status (KPS) ≥ 70;
- Life expectancy ≥ 6 months.
Key exclusion criteria (6 listed)
- Had brain metastases or other concurrent life-threatening diseases;
- Nausea and/or vomiting were present 24h before chemotherapy treatment;
- Suffered from or had a history of gastrointestinal diseases;
- Had a history of head trauma, serious neurological or psychiatric disorders;
- Participating in other clinical trials currently;
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 |
|---|---|---|
| acupuncture (Huatuo)The needles used were Huatuo brand (Suzhou, China) sterile disposable stainless steel filiform; needles sized 0.25*25 mm. After disinfection, needles were inserted 0.5 to 0.8 inches into the skin and were manipulated manually to obtain Deqi. An electric stimulator (Huatuo SDZ-V, Suzhou, China) was connected to the needles and delivered a constant-current, 0.2-ms, density-wave, stimulus of 2 to 10-Hz frequency, level of intensity was as much as tolerable, but not painful to the subjects. The needles were left for 30 minutes and then removed. | Device | Acupuncture 1, Acupuncture 2, Sham acupuncture |
Primary outcome
The scores of Rhodes Index of Nausea, Vomiting and Retching.
Time frame: 24 hours
4 secondary outcomes
Content of 5-hiaa in urine
Time frame: 12 hours
Heart Rate Variability
Time frame: 1 hour
Tachygastria percentage
Time frame: 1 hour
Dosage of antiemetic drugs
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2015.
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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.
Jin, Doctor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture (Huatuo) in people with Lung Neoplasms, run by Xidian University 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 4 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: status not confirmed, as of the sponsor's last update on 22 Jun 2015. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin, Doctor (king-jlm@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The scores of Rhodes Index of Nausea, Vomiting and Retching. (time frame: 24 hours). 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 Jun 2015.