Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Hypnosedation in Relaxing Patients Undergoing Breast Cancer Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03012399
Recruitment Status : Recruiting
First Posted : January 6, 2017
Last Update Posted : May 20, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This clinical trial studies how well hypnosedation works in relaxing and reducing the need for general anesthesia in patients who are undergoing breast cancer surgery. Hypnosedation is a technique that places patients under conscious sedation where they remain awake and numbed during surgery and involves the use of words and images to help patients relax and to affect their thoughts about what is happening during surgery.

Condition or disease Intervention/treatment Phase
Anatomic Stage 0 Breast Cancer AJCC v8 Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage IA Breast Cancer AJCC v8 Anatomic Stage IB Breast Cancer AJCC v8 Prognostic Stage 0 Breast Cancer AJCC v8 Prognostic Stage I Breast Cancer AJCC v8 Prognostic Stage IA Breast Cancer AJCC v8 Prognostic Stage IB Breast Cancer AJCC v8 Behavioral: Hypnosedation Other: Questionnaire Administration Behavioral: Verbal Support Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. Determine the feasibility of conducting a randomized controlled trial (RCT) of hypnosedation (HS) during breast cancer surgery.

SECONDARY OBJECTIVES:

I. Assess the preliminary efficacy of HS with local anesthesia versus (vs) opioid based general anesthesia (GA) on reducing self-reported anxiety, pain, nausea, vomiting, cancer-related symptoms, and surgical complication rates.

II. Preliminarily evaluate changes in immune markers (natural killer cell function, cytokines, and resolution of inflammatory response markers) and endocrine function (epinephrine, norepinephrine, and cortisol).

III. Preliminarily identify changes in neurological activity as assessed through electroencephalogram (EEG) activity.

IV. Preliminarily evaluate the group differences in medical costs.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients undergo hypnosedation performed by a mind-body specialist before surgery begins and continuing until after surgery is complete.

GROUP II: Patients speak to a mind-body specialist before surgery and prior to receiving general anesthesia.

After completion of study intervention, patients are followed up at days 1, 3, 5, 7, and 14.


Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Biobehavioral Effects of Hypnosis During Breast Cancer Surgery
Actual Study Start Date : March 7, 2017
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Group I (hypnosedation)
Patients undergo hypnosedation performed by a mind-body specialist before surgery begins and continuing until after surgery is complete.
 Behavioral: Hypnosedation
Undergo hypnosedation

Other: Questionnaire Administration
Ancillary studies
Active Comparator: Group II (verbal support)
Patients speak to a mind-body specialist before surgery and prior to receiving general anesthesia.
 Other: Questionnaire Administration
Ancillary studies

Behavioral: Verbal Support
Speak with min-body specialist
Other Name: Verbal Support Therapy


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Hypnosedation (HS) feasibility [ Time Frame: Up to 1 day ]
    Will be determined by two criteria: overall accrual and successful delivery of HS. The intervention will be deemed feasible if: 1) >= 30% of enrolled patients consent and >= 60% of enrolled patients in HS complete surgery without the need of general anesthesia. The study will calculate rates, frequencies, and 90% confidence intervals (CIs), as applicable.


Secondary Outcome Measures :
  1. Efficacy of HS [ Time Frame: Up to 1 day ]
    Will estimate the mean differences of these outcomes between groups and corresponding 90% confidence intervals at specified points in time (baseline, during the procedure, if applicable, and post-procedure), as well as across time points, using linear mixed models (LMMs). Will similarly evaluate the difference in the slope of change for these outcomes between arms. Baseline covariates such as those used in the minimization will be controlled for in our analyses. Time-varying predictors (such as electroencephalograms [EEGs]) may be controlled for in additional exploratory analyses. Standard model diagnostics will be applied to check for model assumptions, such as normality of the residual distribution.

  2. Assessment of changes in immune markers and endocrine function [ Time Frame: Up to 14 days post-surgery ]
    Will estimate the mean differences of these outcomes between groups and corresponding 90% confidence intervals at specified points in time (baseline, during the procedure, if applicable, and post-procedure), as well as across time points, using linear mixed models (LMMs). Will similarly evaluate the difference in the slope of change for these outcomes between arms. Baseline covariates such as those used in the minimization will be controlled for in our analyses. Time-varying predictors (such as electroencephalograms [EEGs]) may be controlled for in additional exploratory analyses. Standard model diagnostics will be applied to check for model assumptions, such as normality of the residual distribution.

  3. Changes in EEG activity as assessed using standardized low-resolution brain electromagnetic tomography (sLORETA) [ Time Frame: Baseline up to 14 days post-surgery ]
    One test for each of the nine frequency band pass regions will be conducted as well as voxel-by-voxel t-tests computed for the whole data set. For each subject, power means within the frequency bands will be summed across all electrode sites in both absolute and relative power. Within-group differences will be examined using paired-sample t-tests. Between-group differences will be examined using analysis of covariance (ANCOVA) with the condition as the fixed variable, baseline EEG scores as the covariate, and post intervention scores as the dependent variable. Percent signal changes will be computed at all six time points of interest in our predetermined regions of interest (ROIs).

  4. Group differences in medical costs [ Time Frame: From the date of surgery up to 14 days ]
    Will obtain detailed billing records from the date of surgery to the point of discharge at 14 days (+/- 5 days) and quantify medical costs in two ways. The first method is to apply cost-to-charge ratio to convert charges on the billing records to cost. The second method will identify from the study's institutional database each billing code appearing in patient's professional and technical charges, and calculate costs using Medicare reimbursement rates corresponding to current procedural terminology (CPT) codes. Because medical costs are highly skewed, the study will apply the non-parametric bootstrapping method to compare difference in medical costs between groups.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female clinical stage 0/1 breast cancers patients scheduled to undergo a unilateral, segmental mastectomy +/- sentinel lymph node dissection
  • Able to read, speak, and write English or Spanish

Exclusion Criteria:

  • A significant anxiety disorder
  • Significant pain during core biopsy as reported by the patient
  • Received neoadjuvant chemotherapy, any autoimmune or immunological disease or taking any immune suppression drugs
  • Plastic surgery involvement for oncoplastic reconstruction
  • If surgery is likely greater than 3 hours
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03012399


Contacts
Layout table for location contacts
Contact: Lorenzo Cohen 713-745-4260 lcohen@mdanderson.org

Locations
Layout table for location information
United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Lorenzo Cohen    713-745-4260      
Principal Investigator: Lorenzo Cohen         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Lorenzo Cohen M.D. Anderson Cancer Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
University of Texas MD Anderson Cancer Center Website  This link exits the ClinicalTrials.gov site

Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03012399    
Other Study ID Numbers: 2016-0599
NCI-2018-01241 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2016-0599 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: January 6, 2017    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Breast Carcinoma In Situ
Neoplasms by Site
Neoplasms
Breast Diseases
 Skin Diseases
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type