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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 14 days post-surgery
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 14 days post-surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 14 days post-surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hypnosedation (HS) feasibility
Secondary outcome measures
Assessment of changes in immune markers and endocrine function
Brain
Efficacy of HS
+1 moreTrial 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
2,972 Previous Clinical Trials
1,787,271 Total Patients Enrolled
148 Trials studying Breast Cancer
63,286 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,662 Previous Clinical Trials
40,925,831 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had chemotherapy before surgery, have an autoimmune disease, or am on immune-suppressing drugs.I can read, speak, and write in English or Spanish.My surgery is expected to last more than 3 hours.I experienced significant pain during my core biopsy.I am a woman with early-stage breast cancer planning to have part of my breast and possibly some lymph nodes removed.You have a serious anxiety disorder.I will have a plastic surgeon involved in my breast cancer surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Group II (verbal support)
- Group 2: Group I (hypnosedation)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities for enrollment in this trial?
"Unfortunately, clinicaltrials.gov does not list this trial as actively recruiting any longer; the original post went up on March 7th 2017 and was last updated January 13th 2021. Nonetheless, there are 2,398 other trials in progress that require enrolment at present."
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