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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01179308
Other study ID # 10-610
Secondary ID
Status Terminated
Phase N/A
First received August 10, 2010
Last updated September 13, 2016
Start date August 2010
Est. completion date August 2015

Study information

Verified date September 2016
Source The Cleveland Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Test the effect of combined regiona/general anesthesia on lung cancer recurrence compared to general anesthesia alone.


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.


Other known NCT identifiers
  • NCT00999726

Recruitment information / eligibility

Status Terminated
Enrollment 67
Est. completion date August 2015
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Other:
General-epidural anesthesia
General anesthesia combined with epidural anesthesia
Balanced general anesthesia and postoperative opioids
General anesthesia alone

Locations

Country Name City State
China Shanghai Chest Hospital Shanghai
United States Cleveland Clinic Cleveland Ohio

Sponsors (1)

Lead Sponsor Collaborator
The Cleveland Clinic

Countries where clinical trial is conducted

United States,  China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) up to 5 years after surgery No
Secondary NK cell function Secondary outcomes measured at repeated perioperative time points, include NK cell function, immune-function markers (cytokines, cortisol) and pain. up to three years post procedure No
Secondary Immune function markers Secondary outcomes measured at repeated perioperative time points, include NK cell function, immune-function markers (cytokines, cortisol) and pain. for up to 3 years post procedure No
Secondary Pain Secondary outcomes measured at repeated perioperative time points, include NK cell function, immune-function markers (cytokines, cortisol) and pain. up to 3 years post proceudure No
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