Acupuncture Treatment of Pain in Pancreatic Cancer

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DESCRIPTION (provided by applicant): BACKGROUND: Pancreatic cancer affects approximately 28,000 Americans a year. Approximately 85-90 percent of these patients are first diagnosed when their disease already is locally advanced or metastatic. AT this point, median survival is three to six months. Treatment of pancreatic cancer is predominantly palliative in nature. Pain control is often the most serious challenge: the pancreas has an extensive blood, lymphatic and nerve supply and is surrounded by numerous other abdominal organs. More than 90 percent of patients with advanced pancreatic cancer experience moderate to severe pain. Several surgical and non-operative procedures are used to palliate pancreatic pain, including blocking afferent pain fibers from the pancreas. Data on the efficacy of these approaches are limited and these interventions tend to be used only in select cases. Oncologic management with gemcitabine chemotherapy or radiotherapy reduces pain in a minority of patients. Most patients require opiates for pain control, and the high doses needed often cause undesirable sedation. Basic and clinical research supports acupuncture for the treatment of pain. A randomized trial found that acupuncture helps relieve non-malignant pancreatic pain, suggesting that an early phase trial of acupuncture for pancreatic cancer pain would be warranted. Objectives: To assess the effects of an acupuncture/acupressure intervention on pain, sedation and opiate medication in patients with pancreatic cancer experiencing moderate to severe pain to: i) determine whether controlled trials are warranted and ii) provide data to aid design of further warranted studies. Methods: Initially, a small number of pancreatic cancer patients reporting either high levels of pain or high levels of sedation will be treated in order to finalize the acupuncture prescription and the data collection procedures. We will then accrue patients in a standard two-stage, Phase II design. Patients will receive four sessions of a standardized acupuncture treatment with intervening acupressure over 10 days. Pain, opiate medication and sedation will be assessed for three days at baseline and post-treatment. Patients will be considered to have responded to treatment if they report a pre-specified level of improvement in either pain or sedation. Ten patients will be recruited. If less than two experience responses, the trial will be terminated. Otherwise, an additional 19 patients will be accrued. A Phase III trial will be deemed warranted if there are 6 or more responses in total; this is consistent with a 30 percent response rate.