Breast CancerPhase 2/3NCT05766891
Opioid-Sparing Effects of Nurse-Delivered Hypnosis During Breast Cancer Surgery
A Phase 2/3 study testing Group 1, Group 2 and Group 3 in people with Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Group 1, Group 2 and Group 3
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2023to 31 Dec 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and Women;
- Age 18 or older;
- Scheduled for a unilateral, breast surgical procedure, ± SLND
- Able to read, write and speak English or Spanish
- Able to sign a written informed consent and be willing to follow protocol requirements
Who cannot join
- Extreme mobility issues that preclude participating in the study
- Major thought disorders such as schizophrenia or uncontrolled bipolar disorder or PTSD
- History of chronic opioid use
- Current pain 2 or above on 0-10 scale
- Co-mobilities such as uncontrollable diabetes or hypertension
- Plastic surgery involvement for oncoplastic reconstruction
Show all 9Show fewer
- Surgery is likely greater than 3 hours
- Patients with hearing loss that could preclude HS facilitation
- Known allergy to propofol or other medications used during surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Lorenzo Cohen, MD, 713-745-4260, lcohen@mdanderson.org
Lorenzo Cohen, MD
About this study
To hypnosedation alone given before and during surgery on reducing opioid use after surgery compared to standard general anesthesia given alone or with hypnosedation.
Read the detailed description
OBJECTIVES
The proposed trial will randomize women and men with stage 0/I breast cancer scheduled for a lumpectomy, including excisional biopsy, ± sentinel node biopsy to one of three groups: 1) surgery with a local anesthetic, fentanyl, and HS before and during surgery (HS); 2) HS before surgery with usual care general anesthesia (HS-GA; total intravenous anesthesia rendering the patient unconscious with propofol infusion, airway instrumentation with a laryngeal mask airway or endotracheal tube, fentanyl, and local anesthetic); or 3) Usual care general anesthesia same as HS-GA group (GA). This project will allow further exploration of HS during surgery and to explore the biopsychosocial processes associated with analgesia and opioid use, anesthesia, and pain. We will test the hypotheses that HS during breast cancer surgery leads to reduced analgesia and opioid use, less pain and psychological stress, and faster recovery, as well as being more cost effective than GA or HS before surgery with GA.
Primary Objective:
To determine the efficacy of HS provided by a nurse anesthetist before and during surgery versus HS-GA or GA on reducing morphine equivalent daily dose (MEDD) from day of surgery through post-operative day (POD) 14.
Secondary Objectives:
- To determine the efficacy of HS with local anesthesia vs HS-GA or GA on reducing self-reported and objective pain, anxiety, nausea/vomiting, fatigue, and cognitive dysfunction.
- To evaluate group differences in costs. Using time and motion studies and methods of economic evaluation, we will test the hypothesis that HS before and during surgery will lead to less time spent in the OR and PACU, lower medication use, and less need for clinical staff engagement, leading to lower overall day of surgery-related costs.
- To explore psychosocial factors as moderators of the effects of the intervention and predictors of recovery. Baseline psychosocial factors including absorption, state and trait anxiety, intrusive thoughts, and discomfort intolerance, pain sensitivity, and expectations will moderate the effects of HS and predict outcomes over time.
- Conditions
- Breast Cancer
- Being tested
- Group 1, Group 2, Group 3
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1Behavioural
Participants will receive hypnosedation will be restarted after arriving in the operating room and will continue for the whole time of surgery
Group 2Behavioural
Participants will receive standard general anesthesia and medications to control your pain after arriving in the operating room
Group 3Behavioural
Participants will receive standard general anesthesia and medications during surgery to control your pain.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Participants will receive hypnosedation before and during surgery as well as local anesthesia and pain/nausea medications during surgery Receives: Behavioral: Group 1 |
| Group 2 | Experimental | Participants will receive hypnosedation before surgery and standard general anesthesia during surgery. Receives: Behavioral: Group 2 |
| Group 3 | Experimental | Participants will receive standard general anesthesia alone. You will not receive hypnosedation. Receives: Behavioral: Group 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine Equivalent Daily Dose (MEDD)
To determine the efficacy of HS provided by a nurse anesthetist before and during surgery versus HS-GA or GA on reducing morphine equivalent daily dose (MEDD) from day of surgery through post-operative day (POD) 14.
Measured: through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start12 Oct 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Rising Tide Foundation
- Responsible party
- Sponsor
- Investigators
- Lorenzo Cohen, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05766891
- Sponsor's protocol ID
- 2022-0959
- Other IDs
- NCI-2023-02059, 5R01CA272565, CCR-23-500
- Status last verified
- Sep 2026
- First submitted
- 2 Mar 2023
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid-Sparing Effects of Nurse-Delivered Hypnosis During Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT05766891
- Acronym / sponsor ID
- 2022-0959
- Conditions
- Breast Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Rising Tide Foundation
- Study start
- 12 Oct 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 13 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To hypnosedation alone given before and during surgery on reducing opioid use after surgery compared to standard general anesthesia given alone or with hypnosedation.
Detailed description
OBJECTIVES
The proposed trial will randomize women and men with stage 0/I breast cancer scheduled for a lumpectomy, including excisional biopsy, ± sentinel node biopsy to one of three groups: 1) surgery with a local anesthetic, fentanyl, and HS before and during surgery (HS); 2) HS before surgery with usual care general anesthesia (HS-GA; total intravenous anesthesia rendering the patient unconscious with propofol infusion, airway instrumentation with a laryngeal mask airway or endotracheal tube, fentanyl, and local anesthetic); or 3) Usual care general anesthesia same as HS-GA group (GA). This project will allow further exploration of HS during surgery and to explore the biopsychosocial processes associated with analgesia and opioid use, anesthesia, and pain. We will test the hypotheses that HS during breast cancer surgery leads to reduced analgesia and opioid use, less pain and psychological stress, and faster recovery, as well as being more cost effective than GA or HS before surgery with GA.
Primary Objective:
To determine the efficacy of HS provided by a nurse anesthetist before and during surgery versus HS-GA or GA on reducing morphine equivalent daily dose (MEDD) from day of surgery through post-operative day (POD) 14.
Secondary Objectives:
- To determine the efficacy of HS with local anesthesia vs HS-GA or GA on reducing self-reported and objective pain, anxiety, nausea/vomiting, fatigue, and cognitive dysfunction.
- To evaluate group differences in costs. Using time and motion studies and methods of economic evaluation, we will test the hypothesis that HS before and during surgery will lead to less time spent in the OR and PACU, lower medication use, and less need for clinical staff engagement, leading to lower overall day of surgery-related costs.
- To explore psychosocial factors as moderators of the effects of the intervention and predictors of recovery. Baseline psychosocial factors including absorption, state and trait anxiety, intrusive thoughts, and discomfort intolerance, pain sensitivity, and expectations will moderate the effects of HS and predict outcomes over time.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Behavioral: Group 1Participants will receive hypnosedation before and during surgery as well as local anesthesia and pain/nausea medications during surgery |
| Group 2 | Experimental | Behavioral: Group 2Participants will receive hypnosedation before surgery and standard general anesthesia during surgery. |
| Group 3 | Experimental | Behavioral: Group 3Participants will receive standard general anesthesia alone. You will not receive hypnosedation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and Women;
- Age 18 or older;
- Scheduled for a unilateral, breast surgical procedure, ± SLND
- Able to read, write and speak English or Spanish
- Able to sign a written informed consent and be willing to follow protocol requirements
Key exclusion criteria (9 listed)
- Extreme mobility issues that preclude participating in the study
- Major thought disorders such as schizophrenia or uncontrolled bipolar disorder or PTSD
- History of chronic opioid use
- Current pain 2 or above on 0-10 scale
- Co-mobilities such as uncontrollable diabetes or hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group 1Participants will receive hypnosedation will be restarted after arriving in the operating room and will continue for the whole time of surgery | Behavioural | Group 1 |
| Group 2Participants will receive standard general anesthesia and medications to control your pain after arriving in the operating room | Behavioural | Group 2 |
| Group 3Participants will receive standard general anesthesia and medications during surgery to control your pain. | Behavioural | Group 3 |
Primary outcome
Morphine Equivalent Daily Dose (MEDD)
Time frame: through study completion; an average of 1 year.
To determine the efficacy of HS provided by a nurse anesthetist before and during surgery versus HS-GA or GA on reducing morphine equivalent daily dose (MEDD) from day of surgery through post-operative day (POD) 14.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lorenzo Cohen, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Group 1, Group 2 and Group 3 in people with Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lorenzo Cohen, MD ((713) 745-4260, lcohen@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine Equivalent Daily Dose (MEDD) (time frame: through study completion; an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.