Biobehavioral Effects of Hypnosis During Breast Cancer Surgery



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/1/2018
Start Date:March 7, 2017
End Date:March 2021
Contact:Lorenzo Cohen, PHD
Email:lcohen@mdanderson.org
Phone:713-745-4260

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The goal of this clinical research study is to learn if it is possible to perform a
relaxation method called hypnosedation before and during breast cancer surgery in order to
avoid the need for general anesthesia. The safety of this procedure will also be studied.

On the day of surgery, participant will have the following procedures and tests done before
participant is assigned to 1 of 2 study groups:

- Participant will be asked to complete questionnaires about whether participant has
anxiety, pain, nausea, and fatigue, and about participant's expectations of
hypnosedation. These questionnaires will take about 30 minutes to complete.

- Participant will have an electroencephalogram (EEG) to measure brain electrical
activity. To do this, a net-like cap will be placed over participant's scalp. The EEG
should take about 10 minutes to complete.

The study doctor will discuss the test results with participant and tell participant to which
group participant has been assigned.

Participant will sign a separate consent form for the surgery.

Length of Study:

Participation on this study will be over after the follow-up period (about 14 days after
surgery).

Study Groups:

After participant's test procedures are collected, but before participant begins surgery,
participant 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 participant is in Group 1, participant will receive hypnosedation from before
participant's surgery begins until after participant's surgery is complete. During
hypnosedation, a hypnotherapist (a mind-body specialist) will use words and images to help
participant relax to affect participant's thoughts about what is happening during surgery.
Participant will be put under conscious sedation (meaning participant will be awake during
hyposedation and surgery but will have received a numbing drug and other drugs to control
pain and nausea). Participant may request to receive general anesthesia at any time.

If participant is in Group 2, a mind-body specialist will speak with participant to help
participant relax before the surgery and before participant is given general anesthesia.
Participant will not be conscious during surgery.

Both Groups:

Participant will be given standard drugs to help decrease the risk of pain and side effects.
Participant may ask the study staff for information about how the drugs are given and their
risks.

Before and after participant's surgery, participant will be asked questions about whether
participant has anxiety, pain, and nausea. After participant's surgery, participant will be
asked these questions every 15 minutes and asked about participant's opinion of the surgery.

Participant will have participant's vital signs and brain waves recorded continuously from
before participant's surgery begins until participant is discharged from the hospital.

Blood (about 2 tablespoons each time) will be drawn before, during, and after participant's
surgery for immune function testing.

Follow-Up:

Participant will be called by a study staff member 1, 3, 5, and 7 days after being discharged
from the hospital. Participant will be asked about whether participant has anxiety, pain,
nausea, fatigue, vomiting, and other side effects. These calls will last about 10 minutes
each time.

About 14 days after surgery:

- Blood (about 2 tablespoons) will be drawn for immune function testing.

- Participant will complete questionnaires about whether participant has anxiety, pain,
nausea, fatigue, vomiting, symptoms, and about participant's opinion of the surgery.
These questionnaires will take about 15 minutes to complete.

This is an investigational study. Hypnosedation is a standard relaxation method.

The study doctor can explain how hypnosedation is designed to work.

Up to 50 participants will be enrolled in this study. All will take part at MD Anderson.

Inclusion Criteria:

1. Female Clinical Stage 0/1 breast cancers patients scheduled to undergo a unilateral,
segmental mastectomy ± sentinel lymph node dissection

2. At least 18 years of age.

3. Able to read, speak, and write English or Spanish.

Exclusion Criteria:

1. A significant anxiety disorder.

2. Significant pain during core biopsy as reported by the patient.

3. Received neoadjuvant chemotherapy, any autoimmune or immunological disease or taking
any immune suppression drugs.

4. Plastic surgery involvement for oncoplastic reconstruction.

5. If surgery is likely greater than 3 hours
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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