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 sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03012399.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Temporarily closed to accrual
Contact: Lorenzo Cohen
Phone: 713-745-4260
PRIMARY OBJECTIVE:
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.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorLorenzo Cohen
