Recruiting
Phase 2
Phase 3

Hypnosis

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT05766891

Conditions

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Group 1

Group 2

Group 3

Study Details

Brief summary:

To hypnosedation alone given before and during surgery on reducing opioid use after surgery compared to standard general anesthesia given alone or with hypnosedation.

Conditions

Breast Cancer

Study ID

NCT05766891

Start date

Oct 12, 2023

Status verified date

Mar, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Men and Women;
2. Age 18 or older;
3. Scheduled for a unilateral, breast surgical procedure, ± SLND
4. Able to read, write and speak English or Spanish
5. Able to sign a written informed consent and be willing to follow protocol requirements

Exclusion Criteria:

1. Extreme mobility issues that preclude participating in the study
2. Major thought disorders such as schizophrenia or uncontrolled bipolar disorder or PTSD
3. History of chronic opioid use
4. Current pain 2 or above on 0-10 scale
5. Co-mobilities such as uncontrollable diabetes or hypertension
6. Plastic surgery involvement for oncoplastic reconstruction
7. Have undergone chemotherapy for current breast cancer diagnosis
8. Surgery is likely greater than 3 hours
9. Patients with hearing loss that could preclude HS facilitation
10. Known allergy to propofol or other medications used during surgery

Study Design

Enrollment

225 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Group 1

Participants will receive hypnosedation before and during surgery as well as local anesthesia and pain/nausea medications during surgery

experimental: Group 2

Participants will receive hypnosedation before surgery and standard general anesthesia during surgery.

experimental: Group 3

Participants will receive standard general anesthesia alone. You will not receive hypnosedation.

Interventions

Group 1

Participants will receive hypnosedation will be restarted after arriving in the operating room and will continue for the whole time of surgery

Group 2

Participants will receive standard general anesthesia and medications to control your pain after arriving in the operating room

Group 3

Participants will receive standard general anesthesia and medications during surgery to control your pain.

Primary outcome measure

  • Morphine Equivalent Daily Dose (MEDD) [ Time Frame: through study completion; an average of 1 year. ]

Central Contacts and Locations

Central contacts

Lorenzo Cohen, MD

(713) 745-4260lcohen@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Lorenzo Cohen, MD

713-745-4260lcohen@mdanderson.org

Principal Investigator:

Lorenzo Cohen, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Mar 16, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-03-16.