Intraoperative Acupoint Stimulation to Prevent Post-Operative Nausea and Vomiting (PONV)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer; Post-Operative Nausea and Vomiting
• Intervention / Treatment: Procedure: Electrical Stimulation; Drug: Zofran; Drug: Dexamethasone; Drug: Phenergan; Drug: Pepcid; Behavioral: Questionnaire

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 Type: Interventional
• Enrollment (Actual): 188
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adults at least 18 years of age
2. Female gender
3. History of patient reported PONV, CINV or motion sickness
4. Patients scheduled for Breast Surgery
5. Sign an informed consent indicating they are aware of the investigational nature of this study.

Exclusion Criteria:

1. Patients scheduled for paravertebral block
2. 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
3. Local skin infections at or near the acustimulation site
4. Pre-existing nausea and vomiting, defined as nausea or vomiting requiring pharmacological treatment greater than 3 times in the week preceding screening
5. History of CVA or other central nervous system disorder resulting in residual weakness or paresis of extremity contralateral to the site of disease
6. Grade III or IV upper extremity peripheral neuropathy
7. Cardiac pacemakers. Patients involved in this protocol will receive electrical stimulation. For safety reasons, electrical stimulation should be avoided in patients with pacemakers
8. Metal implants for the treatment extremity. For safety reasons, use of electrical stimulation should be avoided
9. 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.
10. Pregnancy as this would alter anesthesia plan
11. Bowel obstruction
12. Surgery that would not allow access to at least one P6 site.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electrical Stimulation + Standard of Care Antiemetics; 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; Electrical stimulation to the wrist initiated at 1mHz, 1 pulse/second using two leads on a nerve stimulator. Stimulation continued throughout the breast surgery.; Drug: Zofran; 4 mg by vein for 1 dose.; Other Names: Ondansetron; Drug: Dexamethasone; 10 mg by vein for 1 dose.; Other Names: Decadron; Drug: Phenergan; 6.25 mg by vein for 1 dose.; Other Names: Promethazine; Phenazine; Phencen; Prometh; Prorex; V-Gan; Drug: Pepcid; 10 mg by vein for 1 dose.; Other Names: Famotidine; Behavioral: Questionnaire; 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.; Other Names: Survey
Active Comparator: Standard of Care Antiemetics; 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; 4 mg by vein for 1 dose.; Other Names: Ondansetron; Drug: Dexamethasone; 10 mg by vein for 1 dose.; Other Names: Decadron; Drug: Phenergan; 6.25 mg by vein for 1 dose.; Other Names: Promethazine; Phenazine; Phencen; Prometh; Prorex; V-Gan; Drug: Pepcid; 10 mg by vein for 1 dose.; Other Names: Famotidine; Behavioral: Questionnaire; 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.; Other Names: Survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of Electrical Stimulation of P6 Combined with Prophylactic Anti-Emetics Versus Pharmacological Prophylaxis Alone in Preventing the Incidence of Post-Operative Nausea and Vomiting (PONV)	If a participant fails to have complete control of nausea at any time during PACU stay, participant considered as having PONV. Researchers will use a 1-sided chi-squared test of proportions with Type I error of 0.1 to test for difference in PONV incidence. Nausea assessed verbally on an eleven-point scale (0=no nausea to 10=worst nausea imaginable). Vomiting defined as the forceful expulsion of gastric contents from the mouth. Retching, i.e. an active attempt to vomit without expulsion of gastric contents, categorized as vomiting. Complete control defined as no nausea ≥3, vomiting, or use of anti-emetics during PACU stay.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Intraoperative Neuromuscular Blockade Monitor (NMBM) During Surgery for Breast Cancer	Trial feasible if: At least 20% of screened patients meet inclusion criteria,; 50% of patients who meet the inclusion criteria consent, and; 75% of patients within the acupuncture arm complete all procedures.	1 day

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Alicia M. Kowalski, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• University of Texas MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): February 29, 2016
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: June 12, 2015
• First Submitted That Met QC Criteria: June 12, 2015
• First Posted (Estimated): June 16, 2015

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Breast cancer; Questionnaire; Survey; Ondansetron; Dexamethasone; Electrical stimulation; PONV; Famotidine; Decadron; Breast cancer surgery; Zofran; Post-operative nausea and vomiting; Promethazine; Pepcid; Neuromuscular blockade monitor; NMBM; Prophylactic anti-emetics; Phenergan; Phenazine; Phencen; Prometh; Prorex; V-Gan
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Neoplasms by Site; Postoperative Complications; Signs and Symptoms, Digestive; Breast Diseases; Breast Neoplasms; Nausea; Vomiting; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dermatologic Agents; Serotonin Agents; Serotonin Antagonists; Serotonin 5-HT3 Receptor Antagonists; Anti-Ulcer Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Histamine H2 Antagonists; Dexamethasone; Promethazine; Famotidine; Ondansetron
• Other Study ID Numbers: 2015-0170; NCI-2015-01519 (Registry Identifier: NCI CTRP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No