Regional Anesthesia and Lung Cancer Recurrence
|ClinicalTrials.gov Identifier: NCT01179308|
Recruitment Status : Terminated (The principal investigator decided to close this study site.)
First Posted : August 11, 2010
Last Update Posted : September 15, 2016
|Condition or disease||Intervention/treatment|
|Lung Cancer||Other: General-epidural anesthesia Other: Balanced general anesthesia and postoperative opioids|
Surgery is the primary treatment of lung cancer, but surgery releases tumor cells into the systemic circulation. Whether this minimal residual disease results in clinical metastases is a function of host defense. At least three perioperative factors shift the balance toward initiation and progression of minimal residual disease. (1) Surgery per se depresses cell-mediated immunity, reduces concentrations of tumor-related anti-angiogenic factors (e.g., angiostatin and endostatin), and increases concentrations of pro-angiogenic factors such as VEGF. (2) Anesthesia impairs numerous immune functions, including neutrophil, macrophages, dendritic cells, T lymphocytes (T-cell), and Natural killer cell (NK-cell) functions. (3) Opioid analgesics inhibit both cellular and humoral immune function in humans, and promote tumor growth in rodents. Regional analgesia attenuates each of these adverse effects. For example, regional anesthesia largely prevents the neuroendocrine stress response to surgery by blocking afferent neural transmission. With combined regional and general anesthesia/analgesia, the amount of general anesthetic required is much reduced — as is, presumably, immune suppression. And finally, regional analgesia provides superb pain relief, essentially obliterating the need for postoperative opioids. Animal studies show that regional anesthesia improves natural kill cell function and reduces the metastatic burden in animals inoculated with carcinoma cells. Preliminary retrospective data in cancer patients showed, that paravertebral analgesia for breast cancer surgery reduced risk of recurrence or metastasis by 40% during a 2.5 to 4-year follow-up period.
The investigators thus propose to evaluate the effect of combined epidural-general anesthesia compared to general anesthesia on cancer recurrence semi-annually over a period of 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||67 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Supportive Care|
|Official Title:||The Effect of Adding Intraoperative Regional Anesthesia on Cancer Recurrence in Patients Undergoing Lung Cancer Resection|
|Study Start Date :||August 2010|
|Primary Completion Date :||August 2015|
|Study Completion Date :||August 2015|
Active Comparator: General-epidural anesthesia
Epidural and general anesthesia
Other: General-epidural anesthesia
General anesthesia combined with epidural anesthesia
Active Comparator: General anesthesia
General anesthesia alone
Other: Balanced general anesthesia and postoperative opioids
General anesthesia alone
- disease-free survival [ Time Frame: up to 5 years after surgery ]The effect of regional versus general anesthesia on the primary outcome of disease-free survival (time to the earlier or recurrence or death from any cause)
- NK cell function [ Time Frame: up to three years post procedure ]Secondary outcomes measured at repeated perioperative time points, include NK cell function, immune-function markers (cytokines, cortisol) and pain.
- Immune function markers [ Time Frame: for up to 3 years post procedure ]Secondary outcomes measured at repeated perioperative time points, include NK cell function, immune-function markers (cytokines, cortisol) and pain.
- Pain [ Time Frame: up to 3 years post proceudure ]Secondary outcomes measured at repeated perioperative time points, include NK cell function, immune-function markers (cytokines, cortisol) and pain.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01179308
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Shanghai Chest Hospital|
|Principal Investigator:||Andrea Kurz, M.D.||The Cleveland Clinic|