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

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ClinicalTrials.gov Identifier: NCT02473042
Recruitment Status : Recruiting
First Posted : June 16, 2015
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Post-Operative Nausea and Vomiting Breast Cancer Procedure: Electrical Stimulation Drug: Zofran Drug: Dexamethasone Drug: Phenergan Drug: Pepcid Behavioral: Questionnaire Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Intraoperative Electrical Stimulation of the Acupoint P6 to Prevent Post-Operative Nausea and Vomiting in Women Undergoing Breast Cancer Surgery
Actual Study Start Date : February 2016
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


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 Name: Ondansetron

Drug: Dexamethasone
10 mg by vein for 1 dose.
Other Name: 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 Name: 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 Name: 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 Name: Ondansetron

Drug: Dexamethasone
10 mg by vein for 1 dose.
Other Name: 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 Name: 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 Name: Survey




Primary Outcome Measures :
  1. 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) [ Time Frame: 1 day ]

    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.



Secondary Outcome Measures :
  1. Feasibility of Intraoperative Neuromuscular Blockade Monitor (NMBM) During Surgery for Breast Cancer [ Time Frame: 1 day ]

    Trial feasible if:

    1. At least 20% of screened patients meet inclusion criteria,
    2. 50% of patients who meet the inclusion criteria consent, and
    3. 75% of patients within the acupuncture arm complete all procedures.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02473042


Contacts
Contact: Alicia M. Kowalski, MD 713-745-5089

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Alicia M. Kowalski, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02473042     History of Changes
Other Study ID Numbers: 2015-0170
NCI-2015-01519 ( Registry Identifier: NCI CTRP )
First Posted: June 16, 2015    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
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
Famotidine
Questionnaire
Survey

Additional relevant MeSH terms:
Vomiting
Postoperative Nausea and Vomiting
Breast Neoplasms
Nausea
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Dexamethasone acetate
Dexamethasone
Ondansetron
Antiemetics
Diphenhydramine
Famotidine
BB 1101
Promethazine
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents