Malignant Tumor of Ill-defined Site Clinical Trial
Official title:
LCI-NOS-PAIN-001: A Prospective, Pharmacogenomic-Driven Pilot Study of Pain Management in Oncology Outpatients
About half of all cancer patients seen in oncology clinics have pain at initial assessment; pain relief within a one-month period is seen in approximately one third of these patients and pain worsening in about one fifth. Risk factors for under-treatment of cancer pain include age older than 65 years, minority status, and inadequate pain assessment practices. There is a need for better methods of opioid drug/dose selection and identification of risk factors for worsening pain. Pharmacogenomic approaches offer insight into the genetic variables that impact the pharmacokinetic and pharmacodynamic behavior of opioids. Translating pharmacogenomic results into actionable prescribing decisions may ultimately enable a personalized approach to pain management, increasing the chance of significant pain improvement. Cancer outpatients with uncontrolled malignant pain will be offered a pharmacogenomic test through participation in the study. The results of this test will be used to modify their pain regimen, if applicable.
All subjects will be assessed and prescribed a pain regimen as part of standard practice at the initial visit. Subjects will provide a buccal swab for pharmacogenomic testing and will be discharged on their initial pain regimen. After the initial visit, subjects will be asked to rate their daily pain on a scale of 0-10. A coordinator will follow up with the subject within 7 days (Assessment #1). Subjects will be asked to report information about their pain scores, pain medication use, and caffeine intake, in addition to any bothersome symptoms. Subjects who continue to have "uncontrolled pain", are experiencing bothersome symptoms, and/or requests for a drug/dose modification will have his/her drug/dose modified using the pharmacogenomic test results. If the subject has had significant pain improvement, stable mild pain and/or is satisfied with their level of pain at the assessment (regardless of pain score), he/she will be recommended to continue the current drug/dose and return to clinic on day 30 for the final follow-up. Subjects will be told to call if their pain becomes intolerable or if they experience bothersome symptoms after Assessment #1 for further drug/dose modification if needed prior to day 30. The coordinator will follow up with the subjects receiving a drug/dose modification after another 7 days (Assessment #2). Subjects who have now had significant pain improvement, stable mild pain, and/or are satisfied with their level pain at the assessment (regardless of pain score) will continue on the same regimen. If the subjects' pain is still "uncontrolled", they are experiencing bothersome symptoms, and/or they request a drug/dose modification, their drug/dose will be modified accordingly. Subjects will be told to call if needed, otherwise they will be seen in clinic on day 30 (Final Assessment). If the subject experiences intolerable pain prior to any scheduled assessment, the subject will call for appropriate drug/dose modification. ;