Post-Operative Nausea and VomitingNCT02473042
Intraoperative Acupoint Stimulation to Prevent Post-Operative Nausea and Vomiting (PONV)
A study testing Electrical Stimulation, Zofran and Dexamethasone in people with Post-Operative Nausea and Vomiting and Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if light electrical stimulation to the wrist area during surgery is feasible in women having breast surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Post-Operative Nausea and Vomiting, Breast Cancer
- What is being tested?
- Electrical Stimulation, Zofran and Dexamethasone
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2016to 26 Nov 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults at least 18 years of age
- Female gender
- History of patient reported PONV, CINV or motion sickness
- Patients scheduled for Breast Surgery
- Sign an informed consent indicating they are aware of the investigational nature of this study.
Who cannot join
- Patients scheduled for paravertebral block
- Upper extremity deformity contralateral to the site of disease that could interfere with accurate point location or alter the energy pathway as defined by traditional acupuncture theory
- Local skin infections at or near the acustimulation site
- Pre-existing nausea and vomiting, defined as nausea or vomiting requiring pharmacological treatment greater than 3 times in the week preceding screening
- History of CVA or other central nervous system disorder resulting in residual weakness or paresis of extremity contralateral to the site of disease
- Grade III or IV upper extremity peripheral neuropathy
Show all 12Show fewer
- Cardiac pacemakers. Patients involved in this protocol will receive electrical stimulation. For safety reasons, electrical stimulation should be avoided in patients with pacemakers
- Metal implants for the treatment extremity. For safety reasons, use of electrical stimulation should be avoided
- Current acknowledged use of any illicit drugs, medical marijuana (including Marinol), or evidence of alcohol abuse as defined by The American Psychiatric Association criteria. This includes patients who are currently in the recovery process.
- Pregnancy as this would alter anesthesia plan
- Bowel obstruction
- Surgery that would not allow access to at least one P6 site.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Intraoperative Electrical Stimulation of the Acupoint P6 to Prevent Post-Operative Nausea and Vomiting in Women Undergoing Breast Cancer Surgery
The goal of this clinical research study is to learn if light electrical stimulation to the wrist area during surgery is feasible in women having breast surgery.
Read the detailed description
Study Groups:
If you are eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group.
If you are in Group 1, you will receive light electrical stimulation to the wrist area during surgery. You will also receive standard of care drugs to reduce PONV. If you have nausea or you are vomiting after surgery, you will receive additional standard of care drugs for those symptoms. You may ask the study staff for information about how the drugs are given and their risks.
If you are in Group 2, you will receive standard of care drugs to reduce PONV only (you will not receive electrical stimulation). If you have nausea or you are vomiting after surgery, you will receive additional standard of care drugs for those symptoms.
Electrical Stimulation:
The electrical stimulation is applied through a small sticky pad that is connected to a machine called a neuromuscular blockade monitor (NMBN). NMBNs are routinely used by anesthesiologists to monitor drug levels in muscles during surgery.
The pad will be placed on your wrist after you receive anesthesia and removed at the end of surgery so you will not know what group you are in.
Study Procedures:
Both Groups:
- You will have blood (about 2 teaspoons) collected intravenously (through your IV) during surgery. This blood will be used for genetic testing that may explain why people respond differently to treatments for nausea and vomiting.
- You will complete a questionnaire about your pre-treatment expectations and your nausea every 15 minutes after you wake up after surgery until you leave the clinic. It should take about 2-3 minutes to complete the questionnaire each time.
Length of Study:
Your participation in this study will be over once you leave the clinic after surgery.
This is an investigational study. The NMBM monitor is commercially available and FDA approved for use by anesthesiologists to monitor drug levels in the muscles during surgery. Its use in this study to control nausea/vomiting is investigational.
Up to 176 participants will be enrolled in this study. All will be enrolled at MD Anderson.
- Conditions
- Post-Operative Nausea and Vomiting, Breast Cancer
- Being tested
- Electrical Stimulation, Zofran, Dexamethasone, Phenergan, Pepcid
- Keywords
- Post-operative nausea and vomiting, PONV, Breast cancer, Neuromuscular blockade monitor, NMBM, Breast cancer surgery, Prophylactic anti-emetics, Electrical stimulation, Zofran, Ondansetron, Dexamethasone, Decadron, Phenergan, Promethazine, Phenazine, Phencen, Prometh, Prorex, V-Gan, Pepcid
- Medical subject headings
- Vomiting, 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.
Electrical StimulationProcedure or surgery
Electrical stimulation to the wrist initiated at 1mHz, 1 pulse/second using two leads on a nerve stimulator. Stimulation continued throughout the breast surgery.
ZofranDrug
Also called Ondansetron
4 mg by vein for 1 dose.
DexamethasoneDrug
Also called Decadron
10 mg by vein for 1 dose.
PhenerganDrug
Also called Promethazine, Phenazine, Phencen, Prometh
6.25 mg by vein for 1 dose.
PepcidDrug
Also called Famotidine
10 mg by vein for 1 dose.
QuestionnaireBehavioural
Also called Survey
Questionnaire completed about 15 minutes after participant wakes up after surgery, then every 30 minutes until they leave the clinic. It should take about 2 - 3 minutes to complete the questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Electrical Stimulation + Standard of Care Antiemetics | Experimental | Participants receive light electrical stimulation to the wrist area during surgery. Participants also receive standard of care drugs to reduce post-operative nausea and vomiting (PONV).
Questionnaire completed about participant's pre-treatment expectations and their nausea about 15 minutes after they wake up after surgery, then every 30 minutes until they leave the clinic. Receives: Procedure: Electrical Stimulation; Drug: Zofran; Drug: Dexamethasone; Drug: Phenergan; Drug: Pepcid; Behavioral: Questionnaire |
| Standard of Care Antiemetics | Active comparator | Participants receive standard of care drugs to reduce post-operative nausea and vomiting (PONV).
Questionnaire completed about participant's pre-treatment expectations and their nausea about 15 minutes after they wake up after surgery, then every 30 minutes until they leave the clinic. Receives: Drug: Zofran; Drug: Dexamethasone; Drug: Phenergan; Drug: Pepcid; Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Intervention to Prevent Post-Operative Nausea and Vomiting (PONV)
Examine the efficacy of electrical stimulation of P6 combined with prophylactic anti-emetics versus pharmacological prophylaxis alone in preventing the incidence of PONV following breast surgery in patients at high-risk for PONV
Complete control is defined as "No nausea≥3 \& No vomiting \& No use of anti-emetic during PACU stay"
Measured: During stay in post-operative anesthesia care unit, until discharge, an average of 1 day
Secondary outcomes (6)
Feasibility of Conducting Study
Determine the study feasibility where feasibility is defined by at least 20% of screened patients meeting inclusion criteria ability, 50% of these patients consenting, and 75% of patients within the acupuncture study arm completing all procedures
Measured: At study consent and at PACU discharge
Efficacy of Intervention to Prevent Need for Rescue Anti-emetics
Examine the effects of intra-operative NMBM stimulation of P6 on whether or not any anti-emetics were used compared to the control group
Measured: During stay in post-operative anesthesia care unit, until discharge, an average of 1 day
Satisfaction
Examine group differences in post-operative patient satisfaction with PONV management. Participants were asked to rate their satisfaction with their nausea and vomiting management on a scale of 0-10, where "0" equals "very dissatisfied", and "10" equals "extremely satisfied".
Measured: At discharge from post-operative anesthesia care unit
Efficacy of Intervention to Result in Decreased PACU Length-of-stay
Explore if intra-operative NMBM stimulation of P6 results in decreased PACU length-of-stay
Measured: During stay in post-operative anesthesia care unit, until discharge, an average of 1 day
Expectancy
Explore the associations between expectancy and response to P6 stimulation. Step 1 of 2 compares expectancy answers between groups. The expectancy questionnaire asks participants what their expectation is of the effects of the intervention on lowering their nausea after surgery, lowering their pain after surgery, enabling them to cope with nausea and/or pain better, and enabling them to have a better recovery after surgery. Possible answers are "Not at all agree", "A little agree", "Moderately agree", "Mostly agree", and "Completely agree".
Measured: Baseline
Expectancy and Response to P6 Stimulation
Explore the associations between expectancy and response to P6 stimulation. Step 2 of 2 compares baseline expectancy answers and response to P6 stimulation outcome directly, without taking into account group assignment. The P6 stimulation outcome was categorized as "Fail" or "Success", where "Success" is defined as "No nausea≥3 \& No vomiting \& No use of anti-emetic during PACU stay".
Measured: During stay in post-operative anesthesia care unit, until discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2015 (estimated)
- Study start1 Mar 2016
- Primary completion26 Nov 2024
- Study completion26 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post-Operative Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alicia M. Kowalski, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02473042
- Sponsor's protocol ID
- 2015-0170
- Other IDs
- NCI-2015-01519
- Status last verified
- Dec 2025
- First submitted
- 12 Jun 2015
- Last updated
- 5 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Electrical Stimulation of the Acupoint P6 to Prevent Post-Operative Nausea and Vomiting in Women Undergoing Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT02473042
- Acronym / sponsor ID
- 2015-0170
- Conditions
- Post-Operative Nausea and Vomiting, Breast Cancer
- Keywords
- Post-operative nausea and vomiting, PONV, Breast cancer, Neuromuscular blockade monitor, NMBM, Breast cancer surgery, Prophylactic anti-emetics, Electrical stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 26 Nov 2024 (actual)
- Study completion
- 26 Nov 2024 (actual)
- First posted
- 16 Jun 2015 (estimated)
- Results
- Posted 5 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if light electrical stimulation to the wrist area during surgery is feasible in women having breast surgery.
Detailed description
Study Groups:
If you are eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group.
If you are in Group 1, you will receive light electrical stimulation to the wrist area during surgery. You will also receive standard of care drugs to reduce PONV. If you have nausea or you are vomiting after surgery, you will receive additional standard of care drugs for those symptoms. You may ask the study staff for information about how the drugs are given and their risks.
If you are in Group 2, you will receive standard of care drugs to reduce PONV only (you will not receive electrical stimulation). If you have nausea or you are vomiting after surgery, you will receive additional standard of care drugs for those symptoms.
Electrical Stimulation:
The electrical stimulation is applied through a small sticky pad that is connected to a machine called a neuromuscular blockade monitor (NMBN). NMBNs are routinely used by anesthesiologists to monitor drug levels in muscles during surgery.
The pad will be placed on your wrist after you receive anesthesia and removed at the end of surgery so you will not know what group you are in.
Study Procedures:
Both Groups:
- You will have blood (about 2 teaspoons) collected intravenously (through your IV) during surgery. This blood will be used for genetic testing that may explain why people respond differently to treatments for nausea and vomiting.
- You will complete a questionnaire about your pre-treatment expectations and your nausea every 15 minutes after you wake up after surgery until you leave the clinic. It should take about 2-3 minutes to complete the questionnaire each time.
Length of Study:
Your participation in this study will be over once you leave the clinic after surgery.
This is an investigational study. The NMBM monitor is commercially available and FDA approved for use by anesthesiologists to monitor drug levels in the muscles during surgery. Its use in this study to control nausea/vomiting is investigational.
Up to 176 participants will be enrolled in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electrical Stimulation + Standard of Care Antiemetics | Experimental | Procedure: Electrical Stimulation, Drug: Zofran, Drug: Dexamethasone, Drug: Phenergan, Drug: Pepcid, Behavioral: QuestionnaireParticipants receive light electrical stimulation to the wrist area during surgery. Participants also receive standard of care drugs to reduce post-operative nausea and vomiting (PONV). Questionnaire completed about participant's pre-treatment expectations and their nausea about 15 minutes after they wake up after surgery, then every 30 minutes until they leave the clinic. |
| Standard of Care Antiemetics | Active comparator | Drug: Zofran, Drug: Dexamethasone, Drug: Phenergan, Drug: Pepcid, Behavioral: QuestionnaireParticipants receive standard of care drugs to reduce post-operative nausea and vomiting (PONV). Questionnaire completed about participant's pre-treatment expectations and their nausea about 15 minutes after they wake up after surgery, then every 30 minutes until they leave the clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults at least 18 years of age
- Female gender
- History of patient reported PONV, CINV or motion sickness
- Patients scheduled for Breast Surgery
- Sign an informed consent indicating they are aware of the investigational nature of this study.
Key exclusion criteria (12 listed)
- Patients scheduled for paravertebral block
- Upper extremity deformity contralateral to the site of disease that could interfere with accurate point location or alter the energy pathway as defined by traditional acupuncture theory
- Local skin infections at or near the acustimulation site
- Pre-existing nausea and vomiting, defined as nausea or vomiting requiring pharmacological treatment greater than 3 times in the week preceding screening
- History of CVA or other central nervous system disorder resulting in residual weakness or paresis of extremity contralateral to the site of disease
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 |
|---|---|---|
| Electrical StimulationElectrical stimulation to the wrist initiated at 1mHz, 1 pulse/second using two leads on a nerve stimulator. Stimulation continued throughout the breast surgery. | Procedure or surgery | Electrical Stimulation + Standard of Care Antiemetics |
| ZofranAlso: Ondansetron4 mg by vein for 1 dose. | Drug | Electrical Stimulation + Standard of Care Antiemetics, Standard of Care Antiemetics |
| DexamethasoneAlso: Decadron10 mg by vein for 1 dose. | Drug | Electrical Stimulation + Standard of Care Antiemetics, Standard of Care Antiemetics |
| PhenerganAlso: Promethazine, Phenazine, Phencen, Prometh6.25 mg by vein for 1 dose. | Drug | Electrical Stimulation + Standard of Care Antiemetics, Standard of Care Antiemetics |
| PepcidAlso: Famotidine10 mg by vein for 1 dose. | Drug | Electrical Stimulation + Standard of Care Antiemetics, Standard of Care Antiemetics |
| QuestionnaireAlso: SurveyQuestionnaire completed about 15 minutes after participant wakes up after surgery, then every 30 minutes until they leave the clinic. It should take about 2 - 3 minutes to complete the questionnaire. | Behavioural | Electrical Stimulation + Standard of Care Antiemetics, Standard of Care Antiemetics |
Primary outcome
Efficacy of Intervention to Prevent Post-Operative Nausea and Vomiting (PONV)
Time frame: During stay in post-operative anesthesia care unit, until discharge, an average of 1 day
Examine the efficacy of electrical stimulation of P6 combined with prophylactic anti-emetics versus pharmacological prophylaxis alone in preventing the incidence of PONV following breast surgery in patients at high-risk for PONV Complete control is defined as "No nausea≥3 \& No vomiting \& No use of anti-emetic during PACU stay"
6 secondary outcomes
Feasibility of Conducting Study
Time frame: At study consent and at PACU discharge
Efficacy of Intervention to Prevent Need for Rescue Anti-emetics
Time frame: During stay in post-operative anesthesia care unit, until discharge, an average of 1 day
Satisfaction
Time frame: At discharge from post-operative anesthesia care unit
Efficacy of Intervention to Result in Decreased PACU Length-of-stay
Time frame: During stay in post-operative anesthesia care unit, until discharge, an average of 1 day
Expectancy
Time frame: Baseline
Expectancy and Response to P6 Stimulation
Time frame: During stay in post-operative anesthesia care unit, until discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Alicia M. Kowalski, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical Stimulation, Zofran and Dexamethasone in people with Post-Operative Nausea and Vomiting and Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
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 12 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 5 Dec 2025. 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 United States. 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?
Yes. Results are posted in the registry (first posted 5 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Efficacy of Intervention to Prevent Post-Operative Nausea and Vomiting (PONV) (time frame: During stay in post-operative anesthesia care unit, until discharge, an average of 1 day). 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 5 Dec 2025.