Hypnosis for Breast Cancer Surgery

Overseen By Lorenzo Cohen, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Opioids

Disqualifiers: Schizophrenia, Bipolar, PTSD, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

225 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if hypnosis can reduce opioid use after breast cancer surgery compared to traditional anesthesia. Participants will be divided into three groups: one will receive hypnosis (also known as hypnotherapy or clinical hypnosis) and local anesthesia, another will receive hypnosis and standard anesthesia, and the third will receive standard anesthesia alone. The trial seeks individuals diagnosed with early-stage breast cancer who are scheduled for specific surgeries, such as a unilateral segmental mastectomy. As a Phase 2 trial, this study focuses on measuring the effectiveness of hypnosis in reducing opioid use in an initial, smaller group of patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that hypnosis is generally safe during breast cancer surgery. It helps reduce pain, anxiety, and tiredness without causing known side effects. Studies suggest that hypnosis can lessen the need for anesthesia and decrease reported pain levels. Additionally, it might reduce surgery costs by shortening hospital stays. Overall, hypnosis appears to be a well-accepted method for managing discomfort during surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using hypnosis for breast cancer surgery because it offers a unique way to manage pain and anxiety without relying solely on drugs. Unlike standard treatments that typically use general anesthesia, hypnosedation provides a non-invasive, drug-free option that can be used before and during surgery. This approach could minimize the need for heavy sedatives and reduce side effects like nausea. Additionally, with nurse-delivered hypnosis, patients might experience better overall comfort, which could lead to faster recovery times and improved surgical outcomes.

What evidence suggests that nurse-delivered hypnosis is effective for reducing opioid use after breast cancer surgery?

Research has shown that hypnosis can help reduce stress, anxiety, and pain for patients undergoing surgery, including breast cancer surgery. One study found that hypnosis reduced the need for anesthesia, lowered self-reported pain, and even cut costs by shortening surgery time. In this trial, participants in Group 1 will receive hypnosedation before and during surgery, along with local anesthesia and pain/nausea medications. Group 2 participants will receive hypnosedation before surgery and standard general anesthesia during surgery. Group 3 participants will receive standard general anesthesia alone, without hypnosedation. Another study is testing whether hypnosis during breast cancer surgery can improve pain control and reduce the need for opioids. However, a different study found no pain relief benefit from a short hypnosis session before surgery. Overall, the evidence is mixed, but hypnosis has shown promise in reducing pain and the need for anesthesia for some patients. ^{1 2 3 4 5}

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 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.

Inclusion Criteria

Able to sign a written informed consent and be willing to follow protocol requirements.

I am either a man or a woman.

I have been diagnosed with early-stage breast cancer.

Exclusion Criteria

Known allergy to propofol or other medications used during surgery

I will have a plastic surgeon involved in my breast cancer surgery.

I have severe mobility problems that prevent me from joining the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgery with either hypnosedation and local anesthesia, hypnosedation with general anesthesia, or general anesthesia alone

1 day

1 visit (in-person)

Post-operative Monitoring

Participants are monitored for opioid use, pain, anxiety, nausea/vomiting, fatigue, and cognitive dysfunction from the day of surgery through post-operative day 14

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Nurse-Delivered Hypnosis

Trial Overview

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.

How Is the Trial Designed?

Group I: Group 3 Experimental Treatment 3 Interventions

Participants will receive standard general anesthesia alone. You will not receive hypnosedation.

Group II: Group 2 Experimental Treatment 3 Interventions

Participants will receive hypnosedation before surgery and standard general anesthesia during surgery.

Group III: Group 1 Experimental Treatment 3 Interventions

Participants will receive hypnosedation before and during surgery as well as local anesthesia and pain/nausea medications during surgery

Nurse-Delivered Hypnosis is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Hypnotherapy for:

• Anxiety disorders
• Pain management
• Insomnia
• Irritable Bowel Syndrome
• Anxiety related to medical procedures

Approved in European Union as Clinical Hypnosis for:

• Chronic pain
• Anxiety disorders
• Addiction
• Sleep disorders

Approved in Canada as Hypnotherapy for:

• Pain management
• Anxiety disorders
• Insomnia

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+

Rising Tide Foundation

Collaborator

Trials

17

Recruited

6,200+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

In a study of 36 head and neck cancer surgery patients, those who underwent a brief hypnosis intervention experienced significantly shorter postoperative hospital stays compared to those who received usual care without hypnosis.

Higher levels of hypnotizability in patients were associated with fewer surgical complications and less blood loss, suggesting that hypnosis may help improve surgical outcomes and reduce recovery time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guided imagery, hypnosis and recovery from head and neck cancer surgery: an exploratory study. Rapkin, DA., Straubing, M., Holroyd, JC.[2022]

In a randomized controlled trial involving 18 women undergoing breast reduction surgery, those who received 8 sessions of hypnosis showed significantly better wound healing compared to those receiving usual care or supportive attention, with results measured at 1 and 7 weeks post-surgery.

The hypnosis group not only had objectively better healing outcomes but also reported lower pain and improved perceptions of healing, indicating that hypnosis could be a valuable adjunct to surgical recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can medical hypnosis accelerate post-surgical wound healing? Results of a clinical trial. Ginandes, C., Brooks, P., Sando, W., et al.[2010]

In a phase II trial, irinotecan (CPT-11) demonstrated a response rate of 32% for non-small cell lung cancer (NSCLC) and higher rates of 37% and 47% for small cell lung cancer (SCLC), indicating its effectiveness as a treatment option.

Combining CPT-11 with cisplatin showed a promising response rate of 54% in previously untreated NSCLC patients, and adjustments in dosing allowed for a 33% increase in CPT-11 dosage while maintaining safety, suggesting potential for enhanced efficacy in lung cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical studies of irinotecan alone and in combination with cisplatin. Fukuoka, M., Masuda, N.[2019]

Perioperative hypnosis can significantly reduce stress, anxiety, and postoperative pain in breast cancer surgery patients, potentially improving overall recovery and oncological outcomes.

Hypnosis is a cost-effective complementary treatment that may also limit immunosuppression during surgery and enhance wound healing, although further large-scale studies are needed to confirm these benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypnosis in the Perioperative Management of Breast Cancer Surgery: Clinical Benefits and Potential Implications. Potié, A., Roelants, F., Pospiech, A., et al.[2020]

Hypnosis has shown promising effectiveness in reducing pain and emotional distress in women undergoing diagnostic breast biopsy and those with breast cancer, based on a systematic review of 13 randomized controlled trials involving 1357 patients.

While the evidence is still limited, hypnosis may serve as a helpful complementary treatment for managing symptoms like fatigue, nausea, and hot flashes in breast cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypnosis in breast cancer care: a systematic review of randomized controlled trials. Cramer, H., Lauche, R., Paul, A., et al.[2018]

A group intervention combining self-care and self-hypnosis significantly reduced fatigue, sleep disturbances, and emotional distress in 95 female cancer survivors compared to a wait-list control group.

The positive effects of the hypnosis intervention were largely maintained one year after the treatment, suggesting potential long-term benefits for posttreatment cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized, Controlled Trial of an Intervention Combining Self-Care and Self-Hypnosis on Fatigue, Sleep, and Emotional Distress in Posttreatment Cancer Patients: 1-Year Follow-Up. Grégoire, C., Faymonville, ME., Vanhaudenhuyse, A., et al.[2022]

Two studies on hypnosis as an adjuvant therapy for early-stage breast cancer showed that patients experienced reduced depression and increased natural killer (NK) cell counts after 2 months of treatment.

Despite these positive immunological effects, the studies did not assess the clinical significance of hypnosis in terms of actual cancer outcomes, highlighting the need for further research to connect these immune changes to survival rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of the effects of hypnosis on the immune system in breast cancer patients: a brief communication. Hudacek, KD.[2007]

Clinical hypnosis can serve as a powerful adjunct treatment for cancer, addressing both physical symptoms and emotional challenges throughout the patient's journey.

The article outlines a clinical model that uses hypnosis in five phases of cancer treatment, demonstrating its ability to provide symptom relief, enhance healing, and offer emotional support through targeted suggestions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Staying the Course: Using Hypnosis to Help Cancer Patients Navigate Their Illness. Ginandes, C.[2018]

In a study involving 20 women undergoing excisional breast biopsies, brief presurgical hypnosis significantly reduced both postsurgery pain and distress compared to standard care.

The positive effects of hypnosis may be linked to the patients' expectations prior to surgery, suggesting that mindset can play a role in pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief presurgery hypnosis reduces distress and pain in excisional breast biopsy patients. Montgomery, GH., Weltz, CR., Seltz, M., et al.[2007]

A randomized study involving 167 patients found that conversational hypnosis (CH) did not significantly reduce anxiety levels during preoperative wire placement for breast cancer, with similar anxiety scores observed in both CH and control groups after the procedure.

The study was halted early due to futility, indicating that CH did not provide the expected benefits in anxiety reduction or other secondary outcomes, although both groups reported a sense of trust in their caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conversational hypnosis versus standard of care to reduce anxiety in patients undergoing marker placement under radiographic control prior to breast cancer surgery: A randomized, multicenter trial. Lemoine, L., Adam, V., Galus, X., et al.[2022]

A 75-year-old man with advanced gastric cancer achieved a complete response (CR) after receiving a tailored chemotherapy regimen of S-1 and CPT-11, which led to the disappearance of liver metastases and ascites after 5 courses.

The combination therapy was well-tolerated, with only mild adverse events reported, suggesting it could be a promising treatment option for patients with advanced or recurrent gastric cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A case of Stage IV gastric cancer with liver and peritoneal metastases responding completely to tailored S-1/CPT- 11 combination therapy]. Matsutani, T., Suzuki, S., Mizutani, T., et al.[2018]

In a study of seven Japanese patients with progressive or recurrent breast cancer, CPT-11 was used as salvage chemotherapy, showing a partial response in one patient and a treatment duration of up to 68 weeks.

CPT-11 was generally well-tolerated, with only two patients experiencing grade 3 neutropenia, and no cases of grade 3 diarrhea, indicating its safety and efficacy in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Utility of CPT-11 as salvage chemotherapy for progressive or recurrent breast cancer patients with multiple drug resistance]. Fushimi, K., Nakano, S., Kumagai, K., et al.[2018]

CPT-11 was effective in treating four cases of recurrent breast cancer, showing significant responses in metastatic lesions after just one course of therapy, with response periods ranging from 73 to 431 days.

While major adverse reactions included leukopenia and gastrointestinal symptoms, these were manageable with symptomatic treatment and dose adjustments, indicating that CPT-11 can enhance the quality of life for patients who have become tolerant to other therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Four cases of recurrent breast cancer effectively treated by the new antitumor agent, CPT-11 (irinotecan)]. Doihara, H., Takashima, S., Yokoyama, N.[2018]

CPT-11 (Irinotecan) showed promising efficacy in treating recurrent breast cancer that had become resistant to standard therapies like anthracyclines and taxanes, as demonstrated in two reported cases.

Weekly infusions of CPT-11 led to complete and partial responses in skin and soft tissue lesions, along with significant declines in tumor markers (CEA and CA15-3), indicating its potential as a treatment for drug-resistant breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Two cases of postoperative local skin recurrence of breast cancer successfully treated with chemotherapy of irinotecan hydrochloride (CPT-11)]. Enomoto, K., Amano, S., Sakurai, K., et al.[2018]

Citations

1.

reporter.nih.gov

reporter.nih.gov/project-details/11085166

Project Details - NIH RePORTER

We specifically propose to test the hypothesis that HS during breast cancer surgery will result in better analgesia control along with lower opioid use, less ...

2.

withpower.com

withpower.com/trial/hypnosis-for-breast-cancer-surgery-9d89b

Hypnosis for Breast Cancer Surgery

Research shows that hypnosis can help reduce stress, anxiety, pain, and improve wound healing in patients undergoing surgery, including breast cancer ...

3.

reporter.nih.gov

reporter.nih.gov/search/12E0C90B468FC1D47598B8961CAA4A01A2FFCEB861BF/project-details/11045708

Training clinical providers in evidence-based hypnosis for cancer ...

It is estimated that 39% of patients experience pain following curative treatment, 55% during anticancer treatment, 40%of survivors experience pain,and 66% of ...

4.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2696867

Effects of a Hypnosis Session Before General Anesthesia ...

Our study shows no benefit of a short perioperative hypnosis session on postoperative pain in women eligible for minor breast cancer surgery.

5.

academic.oup.com

academic.oup.com/jnci/article/99/17/1304/2522227?login=true

Randomized Clinical Trial of a Brief Hypnosis Intervention to ...

The hypnosis intervention not only reduced use of anesthesia and self-reported pain but also reduced institutional costs for surgery, mainly by reducing time in ...