Contemporary clinical trials
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Contemp Clin Trials · Jul 2008
Randomized Controlled Trial Multicenter StudyCan regional analgesia reduce the risk of recurrence after breast cancer? Methodology of a multicenter randomized trial.
Surgery is the primary and most effective treatment of breast cancer, but minimal residual disease is probably unavoidable. Whether residual disease results in clinical metastases depends on numerous factors, including anti-tumor cell mediated immunity and angiogenic and growth signals in sites of residual disease. At least three perioperative factors adversely affect these: 1) the neuroendocrine stress response to surgery, 2) volatile anesthetics, and 3) opioids. ⋯ Enrolling 1100 patients over 5 years will provide 85% power for detecting a 30% treatment effect at an alpha of 0.05. We plan four equally spaced interim analyses, each evaluating efficacy and futility. Confirming our hypothesis will indicate that a small 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.