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?

To hypnosedation alone given before and during surgery on reducing opioid use after surgery compared to standard general anesthesia given alone or with hypnosedation.

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 hypnosis safe for use in breast cancer surgery?

Research suggests that hypnosis is generally safe for use in breast cancer surgery, as it helps reduce pain, anxiety, and fatigue without reported adverse effects. It is considered a low-cost, complementary treatment option. ^{1 2 3 4 5}

How does nurse-delivered hypnosis differ from other treatments for breast cancer surgery?

Nurse-delivered hypnosis is unique because it uses guided relaxation and focused attention to help manage pain and anxiety during breast cancer surgery, unlike traditional treatments that rely on medications or invasive procedures. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Nurse-Delivered Hypnosis, Hypnotherapy, Clinical 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 surgery. It is also noted to be cost-effective and can enhance emotional support and self-agency during the cancer treatment process. ^{1 11 12 13 14}

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]

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]

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]

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]

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 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 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]

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]

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]

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]

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]

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]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Guided imagery, hypnosis and recovery from head and neck cancer surgery: an exploratory study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Hypnosis in the Perioperative Management of Breast Cancer Surgery: Clinical Benefits and Potential Implications. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Can medical hypnosis accelerate post-surgical wound healing? Results of a clinical trial. [2010]

4. England pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

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

6. England pubmed.ncbi.nlm.nih.gov

Brief presurgery hypnosis reduces distress and pain in excisional breast biopsy patients. [2007]

7. United States pubmed.ncbi.nlm.nih.gov

Hypnosis in breast cancer care: a systematic review of randomized controlled trials. [2018]

8. Switzerland 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. [2022]

9. England 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. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

Clinical studies of irinotecan alone and in combination with cisplatin. [2019]

11. Japan pubmed.ncbi.nlm.nih.gov

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

12. Japan 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]. [2018]

13. Japan pubmed.ncbi.nlm.nih.gov

[Two cases of postoperative local skin recurrence of breast cancer successfully treated with chemotherapy of irinotecan hydrochloride (CPT-11)]. [2018]

14. Japan pubmed.ncbi.nlm.nih.gov

[Utility of CPT-11 as salvage chemotherapy for progressive or recurrent breast cancer patients with multiple drug resistance]. [2018]