Hypnosedation for Breast Cancer Surgery

Overseen By Lorenzo Cohen

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Immune suppression drugs

Disqualifiers: Anxiety disorder, Autoimmune disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

50 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Lorenzo Cohen

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for women with early-stage breast cancer (stage 0/1) who are set to have a specific type of breast surgery without extensive reconstruction. Participants must be able to communicate in English or Spanish and haven't had prior chemotherapy or suffer from autoimmune diseases, significant anxiety disorders, or severe pain during biopsy.

Inclusion Criteria

I can read, speak, and write in English or Spanish.

I am a woman with early-stage breast cancer planning to have part of my breast and possibly some lymph nodes removed.

Exclusion Criteria

I have had chemotherapy before surgery, have an autoimmune disease, or am on immune-suppressing drugs.

My surgery is expected to last more than 3 hours.

I experienced significant pain during my core biopsy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Surgery Preparation

Patients undergo hypnosedation or speak to a mind-body specialist before surgery

1 day

1 visit (in-person)

Surgery and Immediate Post-Surgery

Patients receive hypnosedation or general anesthesia during surgery and are monitored immediately after

1 day

Follow-up

Participants are monitored for safety and effectiveness after surgery

14 days

5 visits (in-person) on days 1, 3, 5, 7, and 14

Treatment Details

Interventions

• Hypnosedation

Trial Overview The study is examining the effectiveness of hypnosedation—a method that uses relaxation techniques and conscious sedation instead of general anesthesia—during certain breast cancer surgeries. It involves using calming words and imagery to help patients stay relaxed while awake.

Participant Groups

Group I: Group I (hypnosedation) Experimental Treatment 2 Interventions

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

Group II: Group II (verbal support) Active Control 2 Interventions

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

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+