Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00418457
Status:
COMPLETED
Last Update Posted:
2020-06-16
First Post:
2007-01-03
Brief Title:
Regional Anesthesia and Breast Cancer Recurrence
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Regional Anesthesia and Breast Cancer Recurrence
Status:
COMPLETED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 anesthesiaanalgesia 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
Detailed Description:
Surgery is the primary and most effective treatment of breast cancer but residual disease in the form of scattered micrometastases and tumor cells are usually unavoidable Whether minimal residual disease results in clinical metastases is a function of host defense and tumor survival and growth At least three perioperative factors shift the balance toward progression of minimal residual disease
1 Surgery per se depresses cell-mediated immunity reduces concentrations of tumor-related anti-angiogenic factors eg angiostatin and endostatin increases concentrations of pro-angiogenic factors such as VEGF and releases growth factors that promote local and distant growth of malignant tissue
2 Anesthesia impairs numerous immune functions including those of neutrophils macrophages dendritic cells T-cell and natural killer cells
3 Opioid analgesics inhibit both cellular and humoral immune function in humans increase angiogenesis and promote breast tumor growth in rodents
However regional analgesia attenuates or prevents each of these adverse effects by largely preventing the neuroendocrine surgical stress response eliminating or reducing the need for general anesthesia and minimizing opioid requirement Animal studies indicate that regional anesthesia and optimum postoperative analgesia independently reduce the metastatic burden in animals inoculated with breast adenocarcinoma cells following surgery Preliminary data in cancer patients are also consistent paravertebral analgesia for breast cancer surgery reduced risk of recurrence or metastasis approximately four-fold 95 CI of estimated hazard ratio is 071 - 006 during a 25 to 4-year follow-up period compared to opioid analgesia The investigators will thus test the hypothesis that recurrence after breast cancer surgery is lower with regional anesthesiaanalgesia than with general anesthesia and opioid analgesia
In this multi-center trial Stage 1-3 patients having mastectomies will be randomly assigned to thoracic epidural or paravertebral anesthesiaanalgesia or to general anesthesia and opioid analgesia As with all time-to-event trials interim and final analyses are based on the number of outcome events recurrences in this case rather than enrollment The number of patients required is just an estimate and varies based on actual recurrence rates which in turn depend on patients stage and grade and ancillary treatments There will be three evenly spaced interim analyses and a final analysis at 351 recurrences Confirming our hypothesis will indicate that a minor modification to anesthetic management one that can be implemented with little risk or cost will reduce the risk of cancer recurrence - a complication that is often ultimately lethal
1 Surgery per se depresses cell-mediated immunity reduces concentrations of tumor-related anti-angiogenic factors eg angiostatin and endostatin increases concentrations of pro-angiogenic factors such as VEGF and releases growth factors that promote local and distant growth of malignant tissue
2 Anesthesia impairs numerous immune functions including those of neutrophils macrophages dendritic cells T-cell and natural killer cells
3 Opioid analgesics inhibit both cellular and humoral immune function in humans increase angiogenesis and promote breast tumor growth in rodents
However regional analgesia attenuates or prevents each of these adverse effects by largely preventing the neuroendocrine surgical stress response eliminating or reducing the need for general anesthesia and minimizing opioid requirement Animal studies indicate that regional anesthesia and optimum postoperative analgesia independently reduce the metastatic burden in animals inoculated with breast adenocarcinoma cells following surgery Preliminary data in cancer patients are also consistent paravertebral analgesia for breast cancer surgery reduced risk of recurrence or metastasis approximately four-fold 95 CI of estimated hazard ratio is 071 - 006 during a 25 to 4-year follow-up period compared to opioid analgesia The investigators will thus test the hypothesis that recurrence after breast cancer surgery is lower with regional anesthesiaanalgesia than with general anesthesia and opioid analgesia
In this multi-center trial Stage 1-3 patients having mastectomies will be randomly assigned to thoracic epidural or paravertebral anesthesiaanalgesia or to general anesthesia and opioid analgesia As with all time-to-event trials interim and final analyses are based on the number of outcome events recurrences in this case rather than enrollment The number of patients required is just an estimate and varies based on actual recurrence rates which in turn depend on patients stage and grade and ancillary treatments There will be three evenly spaced interim analyses and a final analysis at 351 recurrences Confirming our hypothesis will indicate that a minor modification to anesthetic management one that can be implemented with little risk or cost will reduce the risk of cancer recurrence - a complication that is often ultimately lethal
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None