A recruitment feasibility study on the addition of dexamethasone to concurrent opioid therapy in patients with suboptimal cancer related pain management despite standard therapy.

Mater Misericordiae Ltd0 个研究点目标入组 20 人开始时间: 2015年2月3日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•1. age > 18 years
•2. pain related to cancer or its treatment
•3. Brief Pain Inventory-short form (BPI-SF) average pain score greater than or equal to 3 in the previous 24 hours
•4. patients with primarily nociceptive pain (defined as Leeds Assessment of Neuropathic Symptoms and Signs score (LANSS) <12), must have received opioids for at least 48 hours, at or greater than 40mg of oral morphine equivalent per day, unless contraindicated.
•5. patients with predominantly neuropathic pain (LANSS greater than or equal to 12) must have received opioids and at least one antidepressant and/or anticonvulsant for at least 48 hours unless the non-opioid analgesic is specifically contraindicated
•6. no increase in baseline opioid dose within 48 hours before study entry, or planned increase during the study
•7. no increase in co-analgesics within 48 hours of study entry or planned during the duration

•1. Concurrent corticosteroids or use within 7 days of study
•2. Clinician predicted survival less than 28 days
•3. Patients due to receive radiotherapy during or within 4 weeks of study entry
•4. Patients due to commence other therapies during the study period which in the opinion of the investigator may affect pain, including surgery, anaesthetic procedures and chemotherapy.
•5. Medically assessed history of uncontrolled hypertension, uncontrolled cardiac failure, marked fluid retention, or acute sepsis with haemodynamic compromise
•6. Patients with documented uncontrolled diabetes mellitus or active peptic ulcer disease
•7. Patients with documented history of uncontrolled bipolar disorder, schizophrenia, moderate to severe anxiety or depression or a history of steroid induced psychosis

发起方