NCT03012399

Brief 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 words and images to help patients relax and to affect their thoughts about what is happening during surgery.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
12mo left

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Mar 2017Apr 2027

First Submitted

Initial submission to the registry

January 4, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

March 7, 2017

Completed
10.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

10.2 years

First QC Date

January 4, 2017

Last Update Submit

March 3, 2026

Conditions

Anatomic Stage I Breast Cancer AJCC v8Anatomic Stage IA Breast Cancer AJCC v8Anatomic Stage IB Breast Cancer AJCC v8Prognostic Stage 0 Breast Cancer AJCC v8Prognostic Stage I Breast Cancer AJCC v8Prognostic Stage IA Breast Cancer AJCC v8Prognostic Stage IB Breast Cancer AJCC v8Anatomic Stage 0 Breast Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to 1 day

Secondary Outcomes (4)

  • Efficacy of HS

    Up to 1 day

  • Assessment of changes in immune markers and endocrine function

    Up to 14 days post-surgery

  • Changes in EEG activity as assessed using standardized low-resolution brain electromagnetic tomography (sLORETA)

    Baseline up to 14 days post-surgery

  • Group differences in medical costs

    From the date of surgery up to 14 days

Study Arms (2)

Group I (hypnosedation)

EXPERIMENTAL

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

Behavioral: HypnosedationOther: Questionnaire Administration

Group II (verbal support)

ACTIVE COMPARATOR

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

Other: Questionnaire AdministrationBehavioral: Verbal Support

Interventions

HypnosedationBEHAVIORAL

Undergo hypnosedation

Group I (hypnosedation)
Questionnaire AdministrationOTHER

Ancillary studies

Group I (hypnosedation)Group II (verbal support)
Verbal SupportBEHAVIORAL

Speak with min-body specialist

Also known as: Verbal Support Therapy
Group II (verbal support)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Breast Carcinoma In Situ

Interventions

Hypnosis, Anesthetic

Condition Hierarchy (Ancestors)

Carcinoma in SituCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsBreast NeoplasmsNeoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Study Officials

  • Lorenzo Cohen

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2017

First Posted

January 6, 2017

Study Start

March 7, 2017

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

Last Updated

March 5, 2026

Record last verified: 2026-03

Locations

US(1)