ACTRN12615000087550TerminatedPhase 2
A recruitment feasibility study on the addition of dexamethasone to concurrent opioid therapy in patients with suboptimal cancer related pain management despite standard therapy.
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Mater Misericordiae Ltd
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to o limit (—)
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
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