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Behavioral Intervention

Hypnosedation for Breast Cancer Surgery

N/A
Waitlist Available
Led By Lorenzo Cohen
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
If surgery is likely greater than 3 hours
Significant pain during core biopsy as reported by the patient
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 14 days post-surgery
Awards & highlights
No Placebo-Only Group

Summary

This trial will study how well hypnosedation works to relax patients and reduce the need for general anesthesia during breast cancer surgery.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Hypnosedation may lead to potential side effects such as discomfort, anxiety, or insufficient pain control during the procedure. However, it aims to reduce risks associated with general anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman with early-stage breast cancer planning to have part of my breast and possibly some lymph nodes removed.
Select...
I can read, speak, and write in English or Spanish.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My surgery is expected to last more than 3 hours.
Select...
I experienced significant pain during my core biopsy.
Select...
I will have a plastic surgeon involved in my breast cancer surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 14 days post-surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 14 days post-surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hypnosedation (HS) feasibility
Secondary study objectives
Assessment of changes in immune markers and endocrine function
Brain
Efficacy of HS
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group I (hypnosedation)Experimental Treatment2 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 Control2 Interventions
Patients speak to a mind-body specialist before surgery and prior to receiving general anesthesia.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hypnosedation
2022
Completed Phase 4
~60

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,070 Previous Clinical Trials
1,802,758 Total Patients Enrolled
147 Trials studying Breast Cancer
63,203 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,023,120 Total Patients Enrolled
943 Trials studying Breast Cancer
1,443,257 Patients Enrolled for Breast Cancer
Lorenzo CohenPrincipal InvestigatorM.D. Anderson Cancer Center
11 Previous Clinical Trials
58,244 Total Patients Enrolled
1 Trials studying Breast Cancer
452 Patients Enrolled for Breast Cancer

Media Library

Hypnosedation (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03012399 — N/A
Breast Cancer Research Study Groups: Group II (verbal support), Group I (hypnosedation)
Breast Cancer Clinical Trial 2023: Hypnosedation Highlights & Side Effects. Trial Name: NCT03012399 — N/A
Hypnosedation (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03012399 — N/A
~2 spots leftby Apr 2025
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