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Behavioral Intervention
Hypnosis for Breast Cancer Surgery
Phase 2 & 3
Recruiting
Led By Lorenzo Cohen, MD
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
Age 18 or older
Diagnosed with stage 0/1 BCa
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year.
Awards & highlights
Study Summary
This trial showed that hypnosedation can reduce opioid use after surgery compared to general anesthesia alone.
Who is the study for?
This trial is for men and women over 18 with early-stage breast cancer (stage 0/1), scheduled for specific breast surgery, who can understand English or Spanish. Excluded are those with hearing loss, allergies to certain anesthetics, severe mobility issues, uncontrolled diabetes/hypertension, planned complex surgery or reconstruction, prior chemotherapy, low hypnotic suggestibility score, chronic opioid use or major thought disorders.Check my eligibility
What is being tested?
The study tests the effectiveness of nurse-delivered hypnosis before and during surgery in reducing post-surgery opioid use compared to standard anesthesia alone or combined with hypnosis. Participants will be divided into three groups: one receiving only hypnosedation; another receiving standard anesthesia; and a third group getting both treatments.See study design
What are the potential side effects?
Potential side effects may include typical reactions to hypnosis such as dizziness or nausea. Standard anesthesia risks include allergic reactions and respiratory issues. The combination of both treatments could potentially amplify these side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I have been diagnosed with early-stage breast cancer.
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I am scheduled for a partial breast removal surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; an average of 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Trait/State Anxiety Questionnaire
Trial Design
3Treatment groups
Experimental Treatment
Group I: Group 3Experimental Treatment3 Interventions
Participants will receive standard general anesthesia alone. You will not receive hypnosedation.
Group II: Group 2Experimental Treatment3 Interventions
Participants will receive hypnosedation before surgery and standard general anesthesia during surgery.
Group III: Group 1Experimental Treatment3 Interventions
Participants will receive hypnosedation before and during surgery as well as local anesthesia and pain/nausea medications during surgery
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Group 1
2013
Completed Phase 3
~3130
Group 2
2013
Completed Phase 3
~3020
Group 3
2010
N/A
~830
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,092 Total Patients Enrolled
147 Trials studying Breast Cancer
63,061 Patients Enrolled for Breast Cancer
National Institutes of Health (NIH)NIH
2,697 Previous Clinical Trials
7,492,094 Total Patients Enrolled
49 Trials studying Breast Cancer
110,560 Patients Enrolled for Breast Cancer
Lorenzo Cohen, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
30 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can read, write, and speak in English or Spanish.I will have a plastic surgeon involved in my breast cancer surgery.I have severe mobility problems that prevent me from joining the study.You scored low on a test that measures how easily you can be influenced or hypnotized.I have had chemotherapy or am scheduled for surgery lasting more than 3 hours.I am 18 years old or older.I have diabetes or high blood pressure that is not well-controlled.You have been using opioids for a long time.I am either a man or a woman.You have significant hearing loss that may make it difficult for you to participate in the study.I have been diagnosed with early-stage breast cancer.I am scheduled for a partial breast removal surgery.My current pain level is 2 or higher on a scale of 0 to 10.You have severe mental health conditions like schizophrenia, uncontrolled bipolar disorder, or PTSD.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1
- Group 2: Group 2
- Group 3: Group 3
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 any openings currently available for this clinical experience?
"According to the clinicaltrials.gov, this study has finished recruiting and is no longer searching for participants, with its last update on March 2nd 2023. Despite this fact, there are still 2609 other trials actively enrolling patients right now."
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