Hypnosedation in Relaxing Patients Undergoing Breast Cancer Surgery

M.D. Anderson Cancer Center

Status: Active, not recruiting

Conditions: Prognostic Stage IA Breast Cancer AJCC v8; Prognostic Stage IB Breast Cancer AJCC v8; Prognostic Stage I Breast Cancer AJCC v8; Anatomic Stage IB Breast Cancer AJCC v8; Anatomic Stage IA Breast Cancer AJCC v8; Prognostic Stage 0 Breast Cancer AJCC v8; Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage 0 Breast Cancer AJCC v8

Treatments: Behavioral: Hypnosedation; Behavioral: Verbal Support; Other: Questionnaire Administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03012399

P30CA016672 (U.S. NIH Grant/Contract)

2016-0599 (Other Identifier)

NCI-2018-01241 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Group I (hypnosedation)

Experimental group

Description:

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

Treatment:

Other: Questionnaire Administration

Behavioral: Hypnosedation

Group II (verbal support)

Active Comparator group

Description:

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

Treatment:

Other: Questionnaire Administration

Behavioral: Verbal Support