An interventional study of Electrical Stimulation and Zofran in Post-Operative Nausea and Vomiting and Breast Cancer, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-05.
Sponsored by M.D. Anderson Cancer Center · Not applicable, Interventional, and Supportive care
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.
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:
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.
1,100 studies on the registry are indexed under Vomiting; 134 are open to participants now.
This study's enrollment of 188 is above the median of 107 across 935 interventional studies indexed under Vomiting.
Browse Vomiting studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Procedure: Electrical Stimulation · Drug: Zofran · Drug: Dexamethasone · Drug: Phenergan · Drug: Pepcid · Behavioral: Questionnaire
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.
Drug: Zofran · Drug: Dexamethasone · Drug: Phenergan · Drug: Pepcid · Behavioral: Questionnaire
Electrical stimulation to the wrist initiated at 1mHz, 1 pulse/second using two leads on a nerve stimulator. Stimulation continued throughout the breast surgery.
4 mg by vein for 1 dose.
Also known as: Ondansetron
10 mg by vein for 1 dose.
Also known as: Decadron
6.25 mg by vein for 1 dose.
Also known as: Promethazine, Phenazine, Phencen, Prometh, Prorex, V-Gan
10 mg by vein for 1 dose.
Also known as: Famotidine
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.
Also known as: Survey
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"
Time frame: During stay in post-operative anesthesia care unit, until discharge, an average of 1 day
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
Time frame: 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
Time frame: 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".
Time frame: 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
Time frame: 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".
Time frame: 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".
Time frame: During stay in post-operative anesthesia care unit, until discharge
The recruitment period occurred between March 2016 to June 2018. 609 potential patients were identified from the breast surgery schedule and were approached to assess their interest in participation and eligibility screening, of which, 233 patients met eligibility criteria. Of these 233 eligible patients, 188 patients consented to the trial.
| Milestone | Intervention | Control |
|---|---|---|
| Started | 92 | 92 |
| Completed | 86 | 86 |
| Not completed | 6 | 6 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Patient became ineligible after enrollment | 2 | 5 |
| Withdrew: Surgery started before study preparation could be completed | 0 | 1 |
| Withdrew: Pacu data unable to be collected | 3 | 0 |
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"
| Participants | Intervention | Control |
|---|---|---|
| Fail | 19 | 12 |
| Success | 67 | 71 |
| Missing Information | 0 | 3 |
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
| Participants | Entire Study |
|---|---|
| Screened eligible | 233 |
| Consented | 188 |
| Completed study | 86 |
Examine the effects of intra-operative NMBM stimulation of P6 on whether or not any anti-emetics were used compared to the control group
| Participants | Intervention | Control |
|---|---|---|
| No | 45 | 54 |
| Yes | 14 | 11 |
| 0 | 45 | 54 |
| 1 | 6 | 10 |
| 2 | 7 | 1 |
| 3 | 1 | 0 |
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".
| Satisfaction score | Intervention | Control |
|---|---|---|
| Satisfaction | 8.92 ± 2.51 | 9.25 ± 1.79 |
Explore if intra-operative NMBM stimulation of P6 results in decreased PACU length-of-stay
| number of minutes | Intervention | Control |
|---|---|---|
| Efficacy of Intervention to Result in Decreased PACU Length-of-stay | 120 ± 53.07 | 119.46 ± 49.88 |
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".
| Participants | Intervention | Control |
|---|---|---|
| Response to ASES_Coping question: Not at all Agree/A little Agree | 13 | 8 |
| Response to ASES_Coping question: Moderately Agree | 14 | 18 |
| Response to ASES_Coping question: Mostly Agree/Completely Agree | 45 | 37 |
| Response to ASES_Coping question: Missing | 14 | 23 |
| Response to ASES_Nausea question: Not at all Agree/A little Agree | 11 | 6 |
| Response to ASES_Nausea question: Moderately Agree | 18 | 17 |
| Response to ASES_Nausea question: Mostly Agree/Completely Agree | 43 | 40 |
| Response to ASES_Nausea question: Missing | 14 | 23 |
| Response to ASES_Pain question: Not at all Agree/A little Agree | 17 | 17 |
| Response to ASES_Pain question: Moderately Agree | 18 | 18 |
| Response to ASES_Pain question: Mostly Agree/Completely Agree | 37 | 29 |
| Response to ASES_Pain question: Missing | 14 | 23 |
| Response to ASES_Recovery question: Not at all Agree/A little Agree | 14 | 10 |
| Response to ASES_Recovery question: Moderately Agree | 13 | 12 |
| Response to ASES_Recovery question: Mostly Agree/Completely Agree | 45 | 42 |
| Response to ASES_Recovery question: Missing | 14 | 23 |
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".
| Participants | Fail | Success |
|---|---|---|
| Response to ASES_Coping question: Not at all Agree/A little Agree | 6 | 15 |
| Response to ASES_Coping question: Moderately Agree | 6 | 25 |
| Response to ASES_Coping question: Mostly Agree/Completely Agree | 9 | 72 |
| Response to ASES_Coping question: Missing | 10 | 26 |
| Response to ASES_Nausea question: Not at all Agree/A little Agree | 5 | 12 |
| Response to ASES_Nausea question: Moderately Agree | 7 | 27 |
| Response to ASES_Nausea question: Mostly Agree/Completely Agree | 9 | 73 |
| Response to ASES_Nausea question: Missing | 10 | 26 |
| Response to ASES_Pain question: Not at all Agree/A little Agree | 7 | 27 |
| Response to ASES_Pain question: Moderately Agree | 5 | 30 |
| Response to ASES_Pain question: Mostly Agree/Completely Agree | 9 | 56 |
| Response to ASES_Pain question: Missing | 10 | 25 |
| Response to ASES_Recovery question: Not at all Agree/A little Agree | 7 | 17 |
| Response to ASES_Recovery question: Moderately Agree | 4 | 20 |
| Response to ASES_Recovery question: Mostly Agree/Completely Agree | 10 | 76 |
| Response to ASES_Recovery question: Missing | 10 | 25 |
Collected over During stay in post-operative anesthesia care unit, until discharge, an average of 1 day. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | 0/86 (0%) | 0/86 (0%) | 4/86 (4.7%) |
| Control | 0/86 (0%) | 0/86 (0%) | 11/86 (12.8%) |
| Event | Intervention | Control |
|---|---|---|
| Muscle weakness upper limb [right]Musculoskeletal and connective tissue disorders | 0/86 | 3/86 |
| Muscle weakness upper limb [left]Musculoskeletal and connective tissue disorders | 1/86 | 2/86 |
| Numbness in left armNervous system disorders | 1/86 | 2/86 |
| Numbness in right armNervous system disorders | 0/86 | 1/86 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 0/86 | 1/86 |
| Paresthesia [left]Nervous system disorders | 1/86 | 1/86 |
| Paresthesia [right]Nervous system disorders | 0/86 | 1/86 |
| HematomaVascular disorders | 1/86 | 0/86 |
| Age, Continuous(years) | Intervention | Control | Total |
|---|---|---|---|
| Mean | 57.41 ± 10.32 | 58.35 ± 11.71 | 57.88 ± 11.02 |
| Sex: Female, Male(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Female | 86 | 86 | 172 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Hispanic or Latino | 16 | 13 | 29 |
| Not Hispanic or Latino | 69 | 71 | 140 |
| Unknown or Not Reported | 1 | 2 | 3 |
| Race (NIH/OMB)(Participants) | Intervention | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 6 | 9 | 15 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 5 | 4 | 9 |
| White | 71 | 64 | 135 |
| More than one race | 4 | 8 | 12 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Region of Enrollment(participants) | Intervention | Control | Total |
|---|---|---|---|
| United States | 86 | 86 | 172 |
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M.D. Anderson Cancer Center