228) Randomized Comparison of Medtronic Intrathecal Drug Delivery Systems (IDDS) plus Comprehensive Medical Management (CMM) vs. CMM for Unrelieved Cancer Pain

5–15% of cancer patients have unrelieved pain or undesirable side effects despite current best management. IDDS may give better pain control and fewer side effects but there are no randomized clinical trials (RCT). A RCT of IDDS plus CMM vs. CMM alone in patients with unrelieved pain (>5 on 0–10 scale) despite current best management is in progress. The IDDS is the SynchroMed Implantable Drug Delivery System. Outcomes include pain control, quality of life (Brief Pain Inventory, SF-12, Caregiver Quality of Life Survey), and toxicity (National Cancer Institute Common Toxicity Criteria), Health resource utilization data will assess if avoided pain therapy expenditures balance IDDS cost. The study can detect a 20% difference in pain control and toxicity with a target accrual of 200 patients. Over 100 patients have been accrued at 19 centers in 5 countries. The study arms are balanced with respect to pain intensity (VAS), life expectancy, demographic variables, source of cancer pain, and baseline opioid use vs. unacceptable opioid side effects. An interim analysis will present data on patient baseline characteristics; management course at different centers; and effect of therapy on pain scores, quality of life, toxicity, and resource utilization.