Anatomic Stage 0 Breast Cancer AJCC v8NCT03012399
Hypnosedation in Relaxing Patients Undergoing Breast Cancer Surgery
A study testing Hypnosedation, Questionnaire Administration and Verbal Support in people with Anatomic Stage 0 Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8
- What is being tested?
- Hypnosedation, Questionnaire Administration and Verbal Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2017to 30 Apr 2027
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Biobehavioral Effects of Hypnosis During Breast Cancer Surgery
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.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the feasibility of conducting a randomized controlled trial (RCT) of hypnosedation (HS) during breast cancer surgery.
SECONDARY OBJECTIVES:
- 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.
- Conditions
- Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Prognostic Stage 0 Breast Cancer AJCC v8, Prognostic Stage I Breast Cancer AJCC v8
- Being tested
- Hypnosedation, Questionnaire Administration, Verbal Support
- Medical subject headings
- Breast Carcinoma In Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnosedationBehavioural
Undergo hypnosedation
Questionnaire AdministrationOther
Ancillary studies
Verbal SupportBehavioural
Also called Verbal Support Therapy
Speak with min-body specialist
| Study group | Role | What they receive |
|---|---|---|
| Group I (hypnosedation) | Experimental | Patients undergo hypnosedation performed by a mind-body specialist before surgery begins and continuing until after surgery is complete. Receives: Behavioral: Hypnosedation; Other: Questionnaire Administration |
| Group II (verbal support) | Active comparator | Patients speak to a mind-body specialist before surgery and prior to receiving general anesthesia. Receives: Other: Questionnaire Administration; Behavioral: Verbal Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypnosedation (HS) feasibility
Will be determined by two criteria: overall accrual and successful delivery of HS. The intervention will be deemed feasible if: 1) >= 30% of enrolled patients consent and >= 60% of enrolled patients in HS complete surgery without the need of general anesthesia. The study will calculate rates, frequencies, and 90% confidence intervals (CIs), as applicable.
Measured: Up to 1 day
Secondary outcomes (4)
Efficacy of HS
Will estimate the mean differences of these outcomes between groups and corresponding 90% confidence intervals at specified points in time (baseline, during the procedure, if applicable, and post-procedure), as well as across time points, using linear mixed models (LMMs). Will similarly evaluate the difference in the slope of change for these outcomes between arms. Baseline covariates such as those used in the minimization will be controlled for in our analyses. Time-varying predictors (such as electroencephalograms [EEGs]) may be controlled for in additional exploratory analyses. Standard model diagnostics will be applied to check for model assumptions, such as normality of the residual distribution.
Measured: Up to 1 day
Assessment of changes in immune markers and endocrine function
Will estimate the mean differences of these outcomes between groups and corresponding 90% confidence intervals at specified points in time (baseline, during the procedure, if applicable, and post-procedure), as well as across time points, using linear mixed models (LMMs). Will similarly evaluate the difference in the slope of change for these outcomes between arms. Baseline covariates such as those used in the minimization will be controlled for in our analyses. Time-varying predictors (such as electroencephalograms [EEGs]) may be controlled for in additional exploratory analyses. Standard model diagnostics will be applied to check for model assumptions, such as normality of the residual distribution.
Measured: Up to 14 days post-surgery
Changes in EEG activity as assessed using standardized low-resolution brain electromagnetic tomography (sLORETA)
One test for each of the nine frequency band pass regions will be conducted as well as voxel-by-voxel t-tests computed for the whole data set. For each subject, power means within the frequency bands will be summed across all electrode sites in both absolute and relative power. Within-group differences will be examined using paired-sample t-tests. Between-group differences will be examined using analysis of covariance (ANCOVA) with the condition as the fixed variable, baseline EEG scores as the covariate, and post intervention scores as the dependent variable. Percent signal changes will be computed at all six time points of interest in our predetermined regions of interest (ROIs).
Measured: Baseline up to 14 days post-surgery
Group differences in medical costs
Will obtain detailed billing records from the date of surgery to the point of discharge at 14 days (+/- 5 days) and quantify medical costs in two ways. The first method is to apply cost-to-charge ratio to convert charges on the billing records to cost. The second method will identify from the study's institutional database each billing code appearing in patient's professional and technical charges, and calculate costs using Medicare reimbursement rates corresponding to current procedural terminology (CPT) codes. Because medical costs are highly skewed, the study will apply the non-parametric bootstrapping method to compare difference in medical costs between groups.
Measured: From the date of surgery up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study start7 Mar 2017
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage 0 Breast Cancer AJCC v8Studies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lorenzo Cohen, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03012399
- Sponsor's protocol ID
- 2016-0599
- Other IDs
- P30CA016672, NCI-2018-01241, 2016-0599
- Status last verified
- Sep 2026
- First submitted
- 4 Jan 2017
- Last updated
- 14 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 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biobehavioral Effects of Hypnosis During Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT03012399
- Acronym / sponsor ID
- 2016-0599
- Conditions
- Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Prognostic Stage 0 Breast Cancer AJCC v8, Prognostic Stage I Breast Cancer AJCC v8
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Mar 2017 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 6 Jan 2017 (estimated)
- 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.
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.
Detailed description
PRIMARY OBJECTIVES:
- Determine the feasibility of conducting a randomized controlled trial (RCT) of hypnosedation (HS) during breast cancer surgery.
SECONDARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (hypnosedation) | Experimental | Behavioral: Hypnosedation, Other: Questionnaire AdministrationPatients undergo hypnosedation performed by a mind-body specialist before surgery begins and continuing until after surgery is complete. |
| Group II (verbal support) | Active comparator | Other: Questionnaire Administration, Behavioral: Verbal SupportPatients speak to a mind-body specialist before surgery and prior to receiving general anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| HypnosedationUndergo hypnosedation | Behavioural | Group I (hypnosedation) |
| Questionnaire AdministrationAncillary studies | Other | Group I (hypnosedation), Group II (verbal support) |
| Verbal SupportAlso: Verbal Support TherapySpeak with min-body specialist | Behavioural | Group II (verbal support) |
Primary outcome
Hypnosedation (HS) feasibility
Time frame: Up to 1 day
Will be determined by two criteria: overall accrual and successful delivery of HS. The intervention will be deemed feasible if: 1) >= 30% of enrolled patients consent and >= 60% of enrolled patients in HS complete surgery without the need of general anesthesia. The study will calculate rates, frequencies, and 90% confidence intervals (CIs), as applicable.
4 secondary outcomes
Efficacy of HS
Time frame: Up to 1 day
Assessment of changes in immune markers and endocrine function
Time frame: Up to 14 days post-surgery
Changes in EEG activity as assessed using standardized low-resolution brain electromagnetic tomography (sLORETA)
Time frame: Baseline up to 14 days post-surgery
Group differences in medical costs
Time frame: From the date of surgery up to 14 days
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 14 Sep 2026.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Lorenzo Cohen 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 study testing Hypnosedation, Questionnaire Administration and Verbal Support in people with Anatomic Stage 0 Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, 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 2 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 14 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypnosedation (HS) feasibility (time frame: Up to 1 day). 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 14 Sep 2026.