Regional Anesthesia and Lung Cancer Recurrence
Primary Purpose
Lung Cancer
Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
General-epidural anesthesia
Balanced general anesthesia and postoperative opioids
Sponsored by
About this trial
This is an interventional supportive care trial for Lung Cancer focused on measuring regional analgesia, routine general anesthesia, immune system response, lung cancer (stage 1-3)
Eligibility Criteria
Inclusion Criteria:
- Primary non-small cell lung cancer (stage 1-3) as determined according to the IASLC Lung Cancer Staging Project;
- Scheduled for potentially curative tumor resection;
- Written informed consent, including willingness to be randomized to epidural anesthesia/analgesia plus general anesthesia or to general anesthesia and postoperative opioid analgesia.
Exclusion Criteria:
- Any contraindication to epidural anesthesia, (including coagulopathy, abnormal anatomy).
- Any contraindication to midazolam, propofol, sevoflurane, fentanyl, morphine, or hydromorphone.
- Age < 18 or > 85 years old.
- Other cancer not believed by the attending surgeon to be in long-term remission.
Sites / Locations
- Cleveland Clinic
- Shanghai Chest Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
General-epidural anesthesia
General anesthesia
Arm Description
Epidural and general anesthesia
General anesthesia alone
Outcomes
Primary Outcome Measures
disease-free survival
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)
Secondary Outcome Measures
NK cell function
Secondary outcomes measured at repeated perioperative time points, include NK cell function, immune-function markers (cytokines, cortisol) and pain.
Immune function markers
Secondary outcomes measured at repeated perioperative time points, include NK cell function, immune-function markers (cytokines, cortisol) and pain.
Pain
Secondary outcomes measured at repeated perioperative time points, include NK cell function, immune-function markers (cytokines, cortisol) and pain.
Full Information
NCT ID
NCT01179308
First Posted
August 10, 2010
Last Updated
September 13, 2016
Sponsor
The Cleveland Clinic
1. Study Identification
Unique Protocol Identification Number
NCT01179308
Brief Title
Regional Anesthesia and Lung Cancer Recurrence
Official Title
The Effect of Adding Intraoperative Regional Anesthesia on Cancer Recurrence in Patients Undergoing Lung Cancer Resection
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Terminated
Why Stopped
The principal investigator decided to close this study site.
Study Start Date
August 2010 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Test the effect of combined regiona/general anesthesia on lung cancer recurrence compared to general anesthesia alone.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
regional analgesia, routine general anesthesia, immune system response, lung cancer (stage 1-3)
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
General-epidural anesthesia
Arm Type
Active Comparator
Arm Description
Epidural and general anesthesia
Arm Title
General anesthesia
Arm Type
Active Comparator
Arm Description
General anesthesia alone
Intervention Type
Other
Intervention Name(s)
General-epidural anesthesia
Intervention Description
General anesthesia combined with epidural anesthesia
Intervention Type
Other
Intervention Name(s)
Balanced general anesthesia and postoperative opioids
Intervention Description
General anesthesia alone
Primary Outcome Measure Information:
Title
disease-free survival
Description
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)
Time Frame
up to 5 years after surgery
Secondary Outcome Measure Information:
Title
NK cell function
Description
Secondary outcomes measured at repeated perioperative time points, include NK cell function, immune-function markers (cytokines, cortisol) and pain.
Time Frame
up to three years post procedure
Title
Immune function markers
Description
Secondary outcomes measured at repeated perioperative time points, include NK cell function, immune-function markers (cytokines, cortisol) and pain.
Time Frame
for up to 3 years post procedure
Title
Pain
Description
Secondary outcomes measured at repeated perioperative time points, include NK cell function, immune-function markers (cytokines, cortisol) and pain.
Time Frame
up to 3 years post proceudure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primary non-small cell lung cancer (stage 1-3) as determined according to the IASLC Lung Cancer Staging Project;
Scheduled for potentially curative tumor resection;
Written informed consent, including willingness to be randomized to epidural anesthesia/analgesia plus general anesthesia or to general anesthesia and postoperative opioid analgesia.
Exclusion Criteria:
Any contraindication to epidural anesthesia, (including coagulopathy, abnormal anatomy).
Any contraindication to midazolam, propofol, sevoflurane, fentanyl, morphine, or hydromorphone.
Age < 18 or > 85 years old.
Other cancer not believed by the attending surgeon to be in long-term remission.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Kurz, M.D.
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Shanghai Chest Hospital
City
Shanghai
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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Regional Anesthesia and Lung Cancer Recurrence
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