NCT05766891 Opioid-Sparing Effects of Nurse-Delivered Hypnosis During Breast Cancer Surgery
| NCT ID | NCT05766891 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 225 participants |
| Start Date | 2023-10-12 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 225 participants in total. It began in 2023-10-12 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To hypnosedation alone given before and during surgery on reducing opioid use after surgery compared to standard general anesthesia given alone or with hypnosedation.
Eligibility Criteria
Inclusion Criteria: 1. Men and Women; 2. Age 18 or older; 3. Scheduled for a unilateral, breast surgical procedure, ± SLND 4. Able to read, write and speak English or Spanish 5. Able to sign a written informed consent and be willing to follow protocol requirements Exclusion Criteria: 1. Extreme mobility issues that preclude participating in the study 2. Major thought disorders such as schizophrenia or uncontrolled bipolar disorder or PTSD 3. History of chronic opioid use 4. Current pain 2 or above on 0-10 scale 5. Co-mobilities such as uncontrollable diabetes or hypertension 6. Plastic surgery involvement for oncoplastic reconstruction 7. Have undergone chemotherapy for current breast cancer diagnosis 8. Surgery is likely greater than 3 hours 9. Patients with hearing loss that could preclude HS facilitation 10. Known allergy to propofol or other medications used during surgery
Contact & Investigator
Lorenzo Cohen, MD
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT05766891 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05766891 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05766891 currently recruiting?
Yes, NCT05766891 is actively recruiting participants. Contact the research team at lcohen@mdanderson.org for enrollment information.
Where is the NCT05766891 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT05766891 clinical trial?
NCT05766891 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Lorenzo Cohen, MD at M.D. Anderson Cancer Center. The trial plans to enroll 225 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.