225 Participants Needed

Hypnosis for Breast Cancer Surgery

LC
Overseen ByLorenzo Cohen, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

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.

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.12345

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.26789

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.1011121314

Research Team

Lorenzo G Cohen | MD Anderson Cancer Center

Lorenzo Cohen

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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 can read, write, and speak in English or Spanish.
I am 18 years old or older.
See 3 more

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.
See 7 more

Timeline

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

Treatment Details

Interventions

  • Nurse-Delivered Hypnosis
Trial OverviewThe 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.
Participant Groups
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

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

πŸ‡ΊπŸ‡Έ
Approved in United States as Hypnotherapy for:
  • Anxiety disorders
  • Pain management
  • Insomnia
  • Irritable Bowel Syndrome
  • Anxiety related to medical procedures
πŸ‡ͺπŸ‡Ί
Approved in European Union as Clinical Hypnosis for:
  • Chronic pain
  • Anxiety disorders
  • Addiction
  • Sleep disorders
πŸ‡¨πŸ‡¦
Approved in Canada as Hypnotherapy for:
  • Pain management
  • Anxiety disorders
  • Insomnia

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

Findings from Research

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.
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.
Hypnosis in the Perioperative Management of Breast Cancer Surgery: Clinical Benefits and Potential Implications.PotiΓ©, 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.
Can medical hypnosis accelerate post-surgical wound healing? Results of a clinical trial.Ginandes, C., Brooks, P., Sando, W., et al.[2010]

References

Guided imagery, hypnosis and recovery from head and neck cancer surgery: an exploratory study. [2022]
Hypnosis in the Perioperative Management of Breast Cancer Surgery: Clinical Benefits and Potential Implications. [2020]
Can medical hypnosis accelerate post-surgical wound healing? Results of a clinical trial. [2010]
A review of the effects of hypnosis on the immune system in breast cancer patients: a brief communication. [2007]
Staying the Course: Using Hypnosis to Help Cancer Patients Navigate Their Illness. [2018]
Brief presurgery hypnosis reduces distress and pain in excisional breast biopsy patients. [2007]
Hypnosis in breast cancer care: a systematic review of randomized controlled trials. [2018]
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]
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]
Clinical studies of irinotecan alone and in combination with cisplatin. [2019]
[Four cases of recurrent breast cancer effectively treated by the new antitumor agent, CPT-11 (irinotecan)]. [2018]
[A case of Stage IV gastric cancer with liver and peritoneal metastases responding completely to tailored S-1/CPT- 11 combination therapy]. [2018]
[Two cases of postoperative local skin recurrence of breast cancer successfully treated with chemotherapy of irinotecan hydrochloride (CPT-11)]. [2018]
[Utility of CPT-11 as salvage chemotherapy for progressive or recurrent breast cancer patients with multiple drug resistance]. [2018]