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

Condition(s) targeted: Post-Operative Nausea and Vomiting; Breast Cancer

Intervention: Electrical Stimulation (Procedure); Zofran (Drug); Dexamethasone (Drug); Phenergan (Drug); Pepcid (Drug); Questionnaire (Behavioral)

Phase: N/A

Status: Not yet recruiting

Sponsored by: M.D. Anderson Cancer Center

Official(s) and/or principal investigator(s):
Alicia M. Kowalski, MD, Principal Investigator, Affiliation: M.D. Anderson Cancer Center

Overall contact:
Alicia M. Kowalski, MD, Phone: 713-745-5089

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 surgery for breast cancer.

Official title: Intraoperative Electrical Stimulation of the Acupoint P6 to Prevent Post-Operative Nausea and Vomiting in Women Undergoing Breast Cancer Surgery

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Primary outcome: Feasibility of Intraoperative Neuromuscular Blockade Monitor (NMBM) During Surgery for Breast Cancer

Detailed description: Study Groups: If participant is eligible to take part in this study, they 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 participant is in Group 1, they will receive light electrical stimulation to the wrist area during surgery. Participant will also receive standard of care drugs to reduce PONV. If participant has nausea or they are vomiting after surgery, they will receive additional standard of care drugs for those symptoms. Participant may ask the study staff for information about how the drugs are given and their risks. If participant is in Group 2, they will receive standard of care drugs to reduce PONV only (participant will not receive electrical stimulation). If participant has nausea or they are vomiting after surgery, they 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 participant's wrist after they receive anesthesia and removed at the end of surgery so they will not know what group they are in. Study Procedures: Both Groups:

- Participant will have blood (about 2 teaspoons) collected intravenously (through their

IV) during surgery. This blood will be used for genetic testing that may explain why people respond differently to treatments for nausea and vomiting.

- Participant will complete a questionnaire about their pre-treatment expectations and

their nausea about 15 minutes after they wake up after surgery, then every 30 minutes until they leave the clinic. It should take about 2-3 minutes to complete the questionnaire. Length of Study: Patient's participation in this study will be over once they 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

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 with breast cancer scheduled for unilateral segmental mastectomy or modified radical mastectomy with or without sentinel lymph node mapping and/or axillary dissection 5. May have other systemic disease but must not be incapacitated by such disease. Determination of physical status will be based on the classification index established by the American Society of Anesthesiologists (ASA). Eligible patients must meet ASA physical status criteria in category Ill or better 6. Planned surgical procedure as outpatient same day discharge or <24hrs. 7. 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 safety reasons, use of electrical stimulation should be avoided 9. Current acknowledged use of any illicit drugs or evidence of alcohol abuse as defined by The American Psychiatric Association criteria 10. Pregnancy as this would alter anesthesia plan 11. Bowel obstruction

Alicia M. Kowalski, MD, Phone: 713-745-5089

University of Texas MD Anderson Cancer Center, Houston, Texas 77030, United States; Not yet recruiting

University of Texas MD Anderson Cancer Center Website

Starting date: October 2015
Last updated: June 23, 2015