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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-01519 | Registry Identifier | NCI CTRP |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electrical Stimulation + Standard of Care Antiemetics | Experimental | 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. |
|
| Standard of Care Antiemetics | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrical Stimulation | Procedure | Electrical stimulation to the wrist initiated at 1mHz, 1 pulse/second using two leads on a nerve stimulator. Stimulation continued throughout the breast surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| 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" | During stay in post-operative anesthesia care unit, until discharge, an average of 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At study consent and at PACU discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alicia M. Kowalski, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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Of the 188 consented patients, 184 patients were randomized. Four consented patients were excluded from trial before randomization due to: One patient became ineligible after enrollment, one patient's surgery started before study preparation could be completed, and two patients found to be ineligible after enrollment.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Anesthesiologist-provided intraoperative electrical stimulation of P6 with a neuromuscular blockade monitor, combined with prophylactic anti-emetics |
| FG001 | Control | Only prophylactic anti-emetics |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Anesthesiologist-provided intraoperative electrical stimulation of P6 with a neuromuscular blockade monitor, combined with prophylactic anti-emetics |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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" | Posted | Count of Participants | Participants | During stay in post-operative anesthesia care unit, until discharge, an average of 1 day |
|
During stay in post-operative anesthesia care unit, until discharge, an average of 1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Anesthesiologist-provided intraoperative electrical stimulation of P6 with a neuromuscular blockade monitor, combined with prophylactic anti-emetics |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Muscle weakness upper limb [left] | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alicia Kowalski, MD | The University of Texas MD Anderson Cancer Center | (713) 563-5614 | amkowalsk@mdanderson.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 21, 2018 | Sep 30, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 14, 2016 | Dec 11, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D014839 | Vomiting |
| D001943 | Breast Neoplasms |
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D004558 | Electric Stimulation |
| D017294 | Ondansetron |
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| D011398 | Promethazine |
| C000598831 | phenazine |
| D004155 | Diphenhydramine |
| D015738 | Famotidine |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D010812 | Physical Stimulation |
| D008919 | Investigative Techniques |
| D007093 | Imidazoles |
| D001393 | Azoles |
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| Zofran | Drug | 4 mg by vein for 1 dose. |
|
|
| Dexamethasone | Drug | 10 mg by vein for 1 dose. |
|
|
| Phenergan | Drug | 6.25 mg by vein for 1 dose. |
|
|
| Pepcid | Drug | 10 mg by vein for 1 dose. |
|
|
| Questionnaire | Behavioral | 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. |
|
|
| 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 |
| 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". | 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 | 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". | 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". | During stay in post-operative anesthesia care unit, until discharge |
| Surgery started before study preparation could be completed |
|
| PACU data unable to be collected |
|
Only prophylactic anti-emetics
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Only prophylactic anti-emetics
|
|
|
| Secondary | 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 | Feasibility was defined in three different ways, and in accordance with each feasibility definition type, there was a different number of patients analyzed. Per protocol, for the "completed study" feasibility definition, we were only looking at the intervention arm. We were not looking at both arms. | Posted | Count of Participants | Participants | At study consent and at PACU discharge |
|
|
|
| Secondary | 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 | Number of participants analyzed does not match number of participants who completed in participant flow due to missing data | Posted | Count of Participants | Participants | During stay in post-operative anesthesia care unit, until discharge, an average of 1 day |
|
|
|
| Secondary | 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". | Number of participants analyzed does not match number of participants who completed in participant flow due to missing data | Posted | Mean | Standard Deviation | Satisfaction score | At discharge from post-operative anesthesia care unit |
|
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | number of minutes | During stay in post-operative anesthesia care unit, until discharge, an average of 1 day |
|
|
|
|
| Secondary | 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". | Posted | Count of Participants | Participants | No | Baseline |
|
|
|
|
| Secondary | 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". | The statistical analysis was between expectancy response at baseline and response to P6 stimulation outcome of either fail or success during PACU stay until discharge, regardless of group assignment. Number of participants analyzed does not match number of participants who completed in participant flow due to missing data for the P6 stimulation outcome. | Posted | Count of Participants | Participants | No | During stay in post-operative anesthesia care unit, until discharge |
|
|
|
|
| 0 |
| 86 |
| 0 |
| 86 |
| 4 |
| 86 |
| EG001 | Control | Only prophylactic anti-emetics | 0 | 86 | 0 | 86 | 11 | 86 |
| Muscle weakness upper limb [right] | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Numbness in left arm | Nervous system disorders | Systematic Assessment |
|
| Numbness in right arm | Nervous system disorders | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Paresthesia [left] | Nervous system disorders | Systematic Assessment |
|
| Paresthesia [right] | Nervous system disorders | Systematic Assessment |
|
| Hematoma | Vascular disorders | Systematic Assessment |
|
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| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D009325 | Nausea |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D011437 | Propylamines |
| D000588 | Amines |
| D010640 | Phenothiazines |
| D005021 | Ethylamines |
| D001559 | Benzhydryl Compounds |
| D013844 | Thiazoles |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
|
| Completed study |
|
|
| 0 |
|
| 1 |
|
| 2 |
|
| 3 |
|
| Response to ASES_Coping question: Mostly Agree/Completely Agree |
|
| Response to ASES_Coping question: Missing |
|
| Response to ASES_Nausea question: Not at all Agree/A little Agree |
|
| Response to ASES_Nausea question: Moderately Agree |
|
| Response to ASES_Nausea question: Mostly Agree/Completely Agree |
|
| Response to ASES_Nausea question: Missing |
|
| Response to ASES_Pain question: Not at all Agree/A little Agree |
|
| Response to ASES_Pain question: Moderately Agree |
|
| Response to ASES_Pain question: Mostly Agree/Completely Agree |
|
| Response to ASES_Pain question: Missing |
|
| Response to ASES_Recovery question: Not at all Agree/A little Agree |
|
| Response to ASES_Recovery question: Moderately Agree |
|
| Response to ASES_Recovery question: Mostly Agree/Completely Agree |
|
| Response to ASES_Recovery question: Missing |
|
| 0.6029 |
| Superiority |
| Response to ASES_Pain question | Chi-squared | 0.7785 | Superiority |
| Response to ASES_Recovery question (Re-categorized) | Chi-squared | 0.8434 | Superiority |
| Response to ASES_Coping question: Mostly Agree/Completely Agree |
|
| Response to ASES_Coping question: Missing |
|
| Response to ASES_Nausea question: Not at all Agree/A little Agree |
|
| Response to ASES_Nausea question: Moderately Agree |
|
| Response to ASES_Nausea question: Mostly Agree/Completely Agree |
|
| Response to ASES_Nausea question: Missing |
|
| Response to ASES_Pain question: Not at all Agree/A little Agree |
|
| Response to ASES_Pain question: Moderately Agree |
|
| Response to ASES_Pain question: Mostly Agree/Completely Agree |
|
| Response to ASES_Pain question: Missing |
|
| Response to ASES_Recovery question: Not at all Agree/A little Agree |
|
| Response to ASES_Recovery question: Moderately Agree |
|
| Response to ASES_Recovery question: Mostly Agree/Completely Agree |
|
| Response to ASES_Recovery question: Missing |
|
| 0.2747 |
| Other |
| Response to ASES_Pain question (Re-categorized) and P6 stimulation outcome | Chi-squared | 0.5608 | Other |
| Response to ASES_Recovery question (Re-categorized) and P6 stimulation outcome | Chi-squared | 0.1014 | There is no statistically significant association between expectancy and complete PONV control. | Other |