Houston, Texas 77030


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT03012399


Primary Contact:

Principal Investigator
Lorenzo Cohen
M.D. Anderson Cancer Center

Lorenzo Cohen
Phone: 713-745-4260
Email: lcohen@mdanderson.org


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States

Lorenzo Cohen
Phone: 713-745-4260

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.