Regional Anesthesia and Breast Cancer Recurrence
Completed · Phase 3
Conditions studied: Breast Neoplasms
In brief
In this multi-center trial, Stage 1-3 patients having mastectomies or isolated lumpectomy with axillary node dissection will be randomly assigned to thoracic epidural or paravertebral anesthesia/analgesia, or to general anesthesia and morphine analgesia. Participants will be followed for up to 10 years to determine the rate of cancer recurrence or metastasis.
Key facts
- Study ID
- NCT00418457
- Run by
- The Cleveland Clinic
- People needed
- 2108
- Starts
- 2007-01-01
- Expected to finish
- 2019-12-01
- Last updated by the study team
- 2020-06-16
Who can join
Age: 18 and older, up to 85. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Primary breast cancer without known extension beyond the breast and axillary nodes (i.e. believed to be Tumor Stage 1-3, Nodes 0-2)
- Scheduled for unilateral or bilateral mastectomy with or without implant (isolated "lumpectomy" will not qualify)
- Isolated "lumpectomy" with axillary node dissection (anticipated removal of at least five nodes)
- Written informed consent, including willingness to be randomized to morphine or regional analgesia
You may not qualify if…
- Previous surgery for breast cancer (except diagnostic biopsies)
- Inflammatory breast cancer
- Age < 18 or > 85 years old
- Scheduled free flap reconstruction
- ASA Physical Status ≥ 4
- Any contraindication to epidural or paravertebral anesthesia and analgesia (including coagulopathy, abnormal anatomy)
- Any contraindication to midazolam, propofol, sevoflurane, fentanyl, or morphine
- Other cancer not believed by the attending surgeon to be in long-term remission
- Systemic disease believed by the attending surgeon to present ≥ 25% two-year mortality
Where it is running
- Cleveland Clinic Foundation — Cleveland, Ohio, United States
- Medical University of Vienna — Vienna, Austria
- Peking Union Medical College Hospital — Beijing, China
- University of Düsseldorf — Düsseldorf, Germany
- Mater Misericordiae Hospital — Dublin, Ireland
- Tan Tock Seng Hospital — Singapore, Singapore
Full record on ClinicalTrials.gov
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