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



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer, Hospital
Therapuetic Areas:Oncology, Other
Healthy:No
Age Range:18 - Any
Updated:3/23/2019
Start Date:February 2016
End Date:February 2021

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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 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.

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.
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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from
Houston, TX
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