NauseaPhase 2NCT01895010
Acupoint Electric Stimulation Combined With Tropisetron in Preventing and Treating Nausea and Vomiting After TACE
A Phase 2 study testing acupoint electric stimulation and tropisetron in people with Nausea and Vomiting, run by Fudan University at 1 site in China.
Trial summary
Observation on acupoint electric stimulation combined with tropisetron in preventing and treating nausea and vomiting and improving the patient's appetite after TACE for primary or metastatic liver cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nausea, Vomiting, Metastatic Liver Cancer
- What is being tested?
- acupoint electric stimulation and tropisetron
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- Jun 2013to Dec 2014
- Phase
- Phase 2
- 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
- ECOG physical status 0,1,2
- would accept the transcatheter hepatic arterial chemoembolization of primary or metastatic liver cancer patients;
- Adult male and female 3, age 18 years old;
- the chem-scheme of arterial infusion chemotherapy based on oxaliplatin dosage of 200mg;
- signed the informed consent and understand the study design;
- Organ function examination in patients must meet the following laboratory indexes: Neutrophil>500/Ul, hemoglobin > 8 gm/dL, platelet >100000/uL,Creatinine < 2 mg/dL bilirubin < 1.5 mg/dL, , alanine aminotransferase < 3 times the normal value, albumin >30g/L
- understand and complete quality of life scale ;
- women of childbearing age urine pregnancy test was negative.
Who cannot join
- The combined use of other venous chemotherapy within 5 days after TACE;
- skin infection on or near the points;
- skin hyperalgesia, unable to withstand electrical stimulation;
- other confounding factors may cause nausea and vomiting (such as intestinal obstruction, anorexia, etc.);
- heart, cerebrovascular accident history or the history of spinal cord injury;
- intestinal obstruction lead to nausea and vomiting
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- installing pacemaker;
- cognitive dysfunction, unable to finish Scale;
- currently using acupuncture therapy.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Xiaoyan Zhu, Dotral, +08602164175590 ext. 3625, zhuxiaoyan@fudan.edu.cn
Xiaoyan Zhu, doc
About this study
Observation on acupoint electric stimulation combined with tropisetron in preventing and treating nausea and vomiting and improving the patient's appetite after TACE for primary or metastatic liver cancer patients.
Read the detailed description
- Classification of nausea and vomiting, as measured by NCI CTC-AE version 3
- The improvement of appetite, as measure by the classification of Appetite in accordance with NCI CTC-AE version 3.
- Quality of life: use M. D. Anderson symptom scale (the m. d. Anderson Symptom Inventory,MDASI)
- Conditions
- Nausea, Vomiting, Metastatic Liver Cancer
- Being tested
- acupoint electric stimulation, tropisetron
- Keywords
- prevention and treatment, improvement of the patient's appetite, TACE
- Medical subject headings
- Nausea, Vomiting, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupoint electric stimulationDevice
acupoint electric stimulation combined with tropisetron 6mg before TACE
tropisetronDrug
only tropisetron 6mg before TACE
| Study group | Role | What they receive |
|---|---|---|
| Acupoint and tropisetron | Experimental | acupoint electric stimulation combined with tropisetron 6mg before TACE Receives: Device: acupoint electric stimulation |
| tropisetron | Active comparator | treated with tropisetron 6mg before TACE Receives: Drug: tropisetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Classification of nausea and vomiting
Measured: 12 month
Secondary outcomes (1)
The improvement of appetite
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NauseaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zhu xiao yan, Fudan University
- Investigators
- Xiaoyan Zhu, Doc, Principal investigator, Shanghai Cancer Centre, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01895010
- Sponsor's protocol ID
- ESA2013
- Status last verified
- Jul 2013
- First submitted
- 21 Jun 2013
- Last updated
- 10 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Xie J, Chen LH, Ning ZY, Zhang CY, Chen H, Chen Z, Meng ZQ, Zhu XY. Effect of transcutaneous electrical acupoint stimulation combined with palonosetron on chemotherapy-induced nausea and vomiting: a single-blind, randomized, controlled trial. Chin J Cancer. 2017 Jan 10;36(1):6. doi: 10.1186/s40880-016-0176-1.
PubMed 28069044
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupoint Electric Stimulation Combined With Tropisetron in Preventing and Treating Nausea and Vomiting After TACE
- ClinicalTrials.gov ID
- NCT01895010
- Acronym / sponsor ID
- ESA2013
- Conditions
- Nausea, Vomiting, Metastatic Liver Cancer
- Keywords
- prevention and treatment, improvement of the patient's appetite, TACE
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 10 Jul 2013 (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.
Observation on acupoint electric stimulation combined with tropisetron in preventing and treating nausea and vomiting and improving the patient's appetite after TACE for primary or metastatic liver cancer patients.
Detailed description
- Classification of nausea and vomiting, as measured by NCI CTC-AE version 3
- The improvement of appetite, as measure by the classification of Appetite in accordance with NCI CTC-AE version 3.
- Quality of life: use M. D. Anderson symptom scale (the m. d. Anderson Symptom Inventory,MDASI)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupoint and tropisetron | Experimental | Device: acupoint electric stimulationacupoint electric stimulation combined with tropisetron 6mg before TACE |
| tropisetron | Active comparator | Drug: tropisetrontreated with tropisetron 6mg before TACE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ECOG physical status 0,1,2
- would accept the transcatheter hepatic arterial chemoembolization of primary or metastatic liver cancer patients;
- Adult male and female 3, age 18 years old;
- the chem-scheme of arterial infusion chemotherapy based on oxaliplatin dosage of 200mg;
- signed the informed consent and understand the study design;
Key exclusion criteria (9 listed)
- The combined use of other venous chemotherapy within 5 days after TACE;
- skin infection on or near the points;
- skin hyperalgesia, unable to withstand electrical stimulation;
- other confounding factors may cause nausea and vomiting (such as intestinal obstruction, anorexia, etc.);
- heart, cerebrovascular accident history or the history of spinal cord injury;
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 |
|---|---|---|
| acupoint electric stimulationacupoint electric stimulation combined with tropisetron 6mg before TACE | Device | Acupoint and tropisetron |
| tropisetrononly tropisetron 6mg before TACE | Drug | tropisetron |
Primary outcome
Classification of nausea and vomiting
Time frame: 12 month
1 secondary outcome
The improvement of appetite
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2013.
- Derived from this study: PubMed 28069044Xie J, Chen LH, Ning ZY, Zhang CY, Chen H, Chen Z, Meng ZQ, Zhu XY. Effect of transcutaneous electrical acupoint stimulation combined with palonosetron on chemotherapy-induced nausea and vomiting: a single-blind, randomized, controlled trial. Chin J Cancer. 2017 Jan 10;36(1):6. doi: 10.1186/s40880-016-0176-1.
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Nausea, Vomiting
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.
Xiaoyan Zhu, Doc principal investigator
Shanghai Cancer Centre, Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing acupoint electric stimulation and tropisetron in people with Nausea and Vomiting, run by Fudan 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 8 inclusion and 9 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 10 Jul 2013. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Classification of nausea and vomiting (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01895010, which also lists 1 linked publication.
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 10 Jul 2013.