Hypnosedation for Breast Cancer Surgery

Overseen By Lorenzo Cohen

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Immune suppression drugs

Disqualifiers: Anxiety disorder, Autoimmune disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether hypnosedation can relax patients and reduce the need for full anesthesia during breast cancer surgery. Hypnosedation involves staying awake while using calming words and images to achieve relaxation. The trial compares this method to patients receiving standard verbal support before surgery. Women with early-stage breast cancer planning certain types of surgery, who do not have significant anxiety or pain issues, might be suitable candidates.

As an unphased trial, this study provides a unique opportunity for patients to explore innovative relaxation techniques that could enhance their surgical experience.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking immune suppression drugs.

What prior data suggests that hypnosedation is safe for breast cancer surgery?

Research shows that hypnosedation is generally well-tolerated by patients undergoing surgery. Studies have found that this method can help reduce anxiety and pain after breast cancer surgery. For instance, one study discovered that patients who used hypnosedation experienced less long-term pain after surgery compared to those who did not. Another study indicated that hypnosedation might decrease the body's inflammatory response during surgery.

Few reports of serious side effects from hypnosedation suggest it is a safe option for those considering it as part of their surgical treatment. However, as with any medical procedure, discussing personal risks and benefits with healthcare providers is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Hypnosedation for breast cancer surgery is unique because it offers a non-pharmacological approach to managing surgical anxiety and discomfort. Unlike standard anesthesia, which relies on drugs to induce unconsciousness, hypnosedation uses hypnosis to relax patients and reduce pain perception. This technique involves a mind-body specialist guiding patients into a deeply relaxed state before and during surgery. Researchers are excited about this method because it could minimize the need for medications, potentially reducing side effects and recovery time, and it taps into the power of the mind to enhance surgical outcomes.

What evidence suggests that hypnosedation is effective for breast cancer surgery?

Research shows that hypnosedation, which participants in this trial may receive, helps during breast cancer surgery by calming patients and reducing the need for general anesthesia. Studies have found it significantly lowers the body's inflammation during surgery. This method also decreases anxiety and lessens pain after surgery. Additionally, patients using hypnosedation may feel less tired and have a shorter hospital stay. These benefits suggest that hypnosedation can be a good option for those undergoing breast cancer surgery. Another group in this trial will receive verbal support from a mind-body specialist before surgery and prior to receiving general anesthesia. ^{1 2 3 4 6}

Who Is on the Research Team?

Lorenzo Cohen

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I can read, speak, and write in English or Spanish.

I am a woman with early-stage breast cancer planning to have part of my breast and possibly some lymph nodes removed.

Exclusion Criteria

I have had chemotherapy before surgery, have an autoimmune disease, or am on immune-suppressing drugs.

My surgery is expected to last more than 3 hours.

I experienced significant pain during my core biopsy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Surgery Preparation

Patients undergo hypnosedation or speak to a mind-body specialist before surgery

1 day

1 visit (in-person)

Surgery and Immediate Post-Surgery

Patients receive hypnosedation or general anesthesia during surgery and are monitored immediately after

1 day

Follow-up

Participants are monitored for safety and effectiveness after surgery

14 days

5 visits (in-person) on days 1, 3, 5, 7, and 14

What Are the Treatments Tested in This Trial?

Interventions

• Hypnosedation

Trial Overview 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.

How Is the Trial Designed?

Group I: Group I (hypnosedation) Experimental Treatment 2 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 Control 2 Interventions

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

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11718863/

Hypnosis Sedation Used in Breast Oncologic Surgery ... Hypnosis sedation used in breast oncologic surgery significantly decreases perioperative inflammatory reaction.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03012399

Hypnosedation in Relaxing Patients Undergoing Breast ... This clinical trial studies how well hypnosedation works in relaxing and reducing the need for general anesthesia in patients who are ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2696867

Effects of a Hypnosis Session Before General Anesthesia ... No benefit of hypnosis was found on postoperative breast pain; however, hypnosis seems to have other benefits regarding fatigue, anxiety, and patient ...

4. gs.amegroups.org gs.amegroups.org/article/view/91706/html

Effect of hypnosis before general anesthesia on postoperative ... The application of hypnosis before general anesthesia for breast cancer surgery can reduce the degree of anxiety of patients, also reducing postoperative pain.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0960977617307701

The advantages of hypnosis intervention on breast cancer ... Duration of hospitalization was statistically significantly reduced in group II versus group I: 3 versus 4.1 days (p = 0.0000057) for all surgical procedures.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6710682/

Impact of Perioperative Hypnosedation on Postmastectomy ... Results: The study shows a statistically significant lower incidence of postmastectomy chronic pain in HYP group (1/21, 1 patient out of 21 ...