This pilot clinical trial studies how well Scrambler therapy works in reducing pain in patients with pain associated with pancreatic cancer. Pain is a common side effect of pancreatic cancer, and relieving pain may help improve patient survival. Scrambler therapy is given using electrocardiography skin electrodes. The electrodes are placed on the body and the machine directs electrical signals across the skin that send "non-pain" messages back to the brain. These messages may confuse the nervous system and reduce the pain caused by the pancreatic cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03707444.
PRIMARY OBJECTIVES:
I. To determine the change in pain from day 0 to day 28 with scrambler therapy in patients with pancreas cancer pain.
II. To determine changes in the complete Brief Pain Inventory; changes in pain drug use; and changes in quality of life (QOL) using the European Organization for Research and Treatment of Cancer (EORTC) QUALITY OF LIFE QUESTIONNAIRE-PANCREAS 26.
OUTLINE:
Patients undergo Scrambler therapy over 30 minutes for 10 days (Monday-Friday for 2 weeks). At the beginning of each session, the device is tested to determine the maximum tolerated intensity setting and best electrode placement. Once the maximum setting and electrode placement have been determined, patients undergo 30 minutes of therapy. Patients also keep a diary recording their use of pain medication.
After completion of study treatment, patients are followed up at 4 and 12 weeks.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationJohns Hopkins University/Sidney Kimmel Cancer Center
Principal InvestigatorThomas J. Smith