Mammary CancerP6 and PONVNCT05408676
Comparison of Dexamethasone Alone vs in Combination With Pericardium 6 (P6) Electrical Stimulation or Granisetron in the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Breast Cancer Surgery
A study testing electric stimulation therapy in people with Mammary Cancer and PONV, run by Fudan University at 1 site in China.
Trial summary
Breast cancer is one of the three most common cancers worldwide, and the primary treatment method is surgery.Since most patients are non-smokers who use opioids in the postoperative period, which are known risk factors for postoperative nausea and vomiting (PONV) according to the Apfel Risk Score. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Mammary Cancer, PONV
- What is being tested?
- electric stimulation therapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 198 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2022to 2 May 2023
- 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 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women undergoing breast cancer resection under general anesthesia
- aged between 18 to 65
- American Society of Anesthesiologists grade I-II
Who cannot join
- using antiemetic drugs within 24 h before operation,
- nausea or vomiting within 24 h before operation;
- Alcoholic or drug abuse,
- abnormal liver and/or kidney function, diabetic or peripheral neuropathy patients, cardiovascular disease (excluding those with controlled hypertension).
- refuse to participate clinical trial
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
About this study
Breast cancer is one of the three most common cancers worldwide, and the primary treatment method is surgery.Since most patients are non-smokers who use opioids in the postoperative period, which are known risk factors for postoperative nausea and vomiting (PONV) according to the Apfel Risk Score. Breast surgery was identified as a strong risk factor for PONV. According to the previous studies, the incidence of PONV is 30-70% in patients undergoing the breast cancer surgery, which not only gives patients unpleasant and painful experience, but also prolongs the hospital stays and delay patient discharge and adds to hospital costs. We compared the effects of dexamethasone alone vs. in combination with Pericardium 6 (P6) electrical stimulation or granisetron for inhibition of PONV in women undergoing breast cancer surgery.
Read the detailed description
186 patients who are planed to undergo elective breast cancer surgery under general anaesthesia into the following three groups: acupoint stimulation+dexamethasone (Group Acu, n=62), granisetron +dexamethasone (Group Gra, n=62), and dexamethasone alone (Group Dxm, n=62). The incidence of nausea, vomiting, and need for rescue antiemetics was recorded 2, 6, 24, and 48 h after surgery.
- Conditions
- Mammary Cancer, PONV
- Being tested
- electric stimulation therapy
- Keywords
- Mammary Cancer, PONV, electric stimulation therapy, antiemetics
- Medical subject headings
- Breast Neoplasms, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electric stimulation therapyDevice
Transcutaneous electrical acupoint stimulation (TEAS) was achieved by an electrical neuromuscular stimulation device (JNR2; designed by the Department of Hand Surgery, Huashan Hospital, Fudan University, manufactured by Energy Conservation and Environment Protection Technology Company, Jiatong University, Shanghai,China)
| Study group | Role | What they receive |
|---|---|---|
| Group Acu | Experimental | a surface electrode was applied in the induction room to the P6 acupoint on the dominant upper extremity, located ∼4 cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode on the opposing dorsal aspect of the forearm. When the patient enters the operating room， an investigator connected the device to both electrodes with electrical wires, set initial electric stimulating current at 1 mA with the frequency at 2 Hz(square-wave pulses of 0.2 ms), gradually increased the current intensity until the patient felt pain or reached the discomfort threshold (ranging from 6 to 20 mA), and maintained the stimulation until end of operation.
At the start of skin closure, saline (3 ml) was administered i.v. Receives: Device: electric stimulation therapy |
| Group Gra | Sham comparator | Group Gra receive the same protocol but silicone covers were attached to both electrodesin to achieve an inert control.
At the start of skin closure, granisetron (3 mg; Group Trp) was administered i.v. Receives: Device: electric stimulation therapy |
| Group Dxm | Sham comparator | Group Dxm receive the same protocol but silicone covers were attached to both electrodesin to achieve an inert control.
At the start of skin closure, saline (3 ml) was administered i.v. Receives: Device: electric stimulation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PONV within the first 24h after surgery
the incidence and severity of PONV
Measured: 24 hours after surgery.
Secondary outcomes (3)
PONV within the first 48h after surgery
the incidence and severity of PONV
Measured: 48 hours after surgery
the use of postoperative antiemetics
the frequency and dose of postoperative antiemetics
Measured: 48 hours after surgery
postoperative pain score
Numeric rating scale (NRS) at 2,6,24,48 hour and 3 month after the surgery
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start10 Jun 2022
- Primary completion30 Mar 2023
- Study completion2 May 2023
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 Mammary CancerStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Zhang, Fudan University
- Investigators
- Jun Zhang, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05408676
- Sponsor's protocol ID
- 2110244-11
- Acronym
- P6 and PONV
- Status last verified
- Sep 2023
- First submitted
- 30 May 2022
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Luo L, Yang L, Lou F, Zhang J. Transcutaneous Pericardium 6 Acupoint Electrical Stimulation Provides Comparable Antiemetic Effect to Granisetron When Combined With Dexamethasone in Patients Undergoing Breast Cancer Surgery. J Surg Res. 2024 Nov;303:81-88. doi: 10.1016/j.jss.2024.08.016. Epub 2024 Sep 19.
PubMed 39303649
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dexamethasone Alone vs in Combination With Pericardium 6 (P6) Electrical Stimulation or Granisetron in the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT05408676
- Acronym / sponsor ID
- P6 and PONV / 2110244-11
- Conditions
- Mammary Cancer, PONV
- Keywords
- Mammary Cancer, PONV, electric stimulation therapy, antiemetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 2 May 2023 (actual)
- First posted
- 7 Jun 2022 (actual)
- 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.
Breast cancer is one of the three most common cancers worldwide, and the primary treatment method is surgery.Since most patients are non-smokers who use opioids in the postoperative period, which are known risk factors for postoperative nausea and vomiting (PONV) according to the Apfel Risk Score. Breast surgery was identified as a strong risk factor for PONV. According to the previous studies, the incidence of PONV is 30-70% in patients undergoing the breast cancer surgery, which not only gives patients unpleasant and painful experience, but also prolongs the hospital stays and delay patient discharge and adds to hospital costs. We compared the effects of dexamethasone alone vs. in combination with Pericardium 6 (P6) electrical stimulation or granisetron for inhibition of PONV in women undergoing breast cancer surgery.
Detailed description
186 patients who are planed to undergo elective breast cancer surgery under general anaesthesia into the following three groups: acupoint stimulation+dexamethasone (Group Acu, n=62), granisetron +dexamethasone (Group Gra, n=62), and dexamethasone alone (Group Dxm, n=62). The incidence of nausea, vomiting, and need for rescue antiemetics was recorded 2, 6, 24, and 48 h after surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group Acu | Experimental | Device: electric stimulation therapya surface electrode was applied in the induction room to the P6 acupoint on the dominant upper extremity, located ∼4 cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode on the opposing dorsal aspect of the forearm. When the patient enters the operating room， an investigator connected the device to both electrodes with electrical wires, set initial electric stimulating current at 1 mA with the frequency at 2 Hz(square-wave pulses of 0.2 ms), gradually increased the current intensity until the patient felt pain or reached the discomfort threshold (ranging from 6 to 20 mA), and maintained the stimulation until end of operation. At the start of skin closure, saline (3 ml) was administered i.v. |
| Group Gra | Sham comparator | Device: electric stimulation therapyGroup Gra receive the same protocol but silicone covers were attached to both electrodesin to achieve an inert control. At the start of skin closure, granisetron (3 mg; Group Trp) was administered i.v. |
| Group Dxm | Sham comparator | Device: electric stimulation therapyGroup Dxm receive the same protocol but silicone covers were attached to both electrodesin to achieve an inert control. At the start of skin closure, saline (3 ml) was administered i.v. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- women undergoing breast cancer resection under general anesthesia
- aged between 18 to 65
- American Society of Anesthesiologists grade I-II
Key exclusion criteria (5 listed)
- using antiemetic drugs within 24 h before operation,
- nausea or vomiting within 24 h before operation;
- Alcoholic or drug abuse,
- abnormal liver and/or kidney function, diabetic or peripheral neuropathy patients, cardiovascular disease (excluding those with controlled hypertension).
- refuse to participate clinical trial
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 |
|---|---|---|
| electric stimulation therapyTranscutaneous electrical acupoint stimulation (TEAS) was achieved by an electrical neuromuscular stimulation device (JNR2; designed by the Department of Hand Surgery, Huashan Hospital, Fudan University, manufactured by Energy Conservation and Environment Protection Technology Company, Jiatong University, Shanghai,China) | Device | Group Acu, Group Dxm, Group Gra |
Primary outcome
PONV within the first 24h after surgery
Time frame: 24 hours after surgery.
the incidence and severity of PONV
3 secondary outcomes
PONV within the first 48h after surgery
Time frame: 48 hours after surgery
the use of postoperative antiemetics
Time frame: 48 hours after surgery
postoperative pain score
Time frame: 3 months after surgery
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 26 Sep 2023.
- Derived from this study: PubMed 39303649Luo L, Yang L, Lou F, Zhang J. Transcutaneous Pericardium 6 Acupoint Electrical Stimulation Provides Comparable Antiemetic Effect to Granisetron When Combined With Dexamethasone in Patients Undergoing Breast Cancer Surgery. J Surg Res. 2024 Nov;303:81-88. doi: 10.1016/j.jss.2024.08.016. Epub 2024 Sep 19.
- Individual participant dataSharing planned: No
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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.
Jun Zhang, PhD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electric stimulation therapy in people with Mammary Cancer and PONV, 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 3 inclusion and 5 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 26 Sep 2023. 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?
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?
PONV within the first 24h after surgery (time frame: 24 hours after surgery.). 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 NCT05408676, 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 26 Sep 2023.