A feasibility study for the addition of parenteral dexamethasone to concurrent opioid therapy in patients with cancer related pain.
- Conditions
- Ongoing cancer related pain despite standard therapy.Cancer - Any cancer
- Registration Number
- ACTRN12615000087550
- Lead Sponsor
- Mater Misericordiae Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 20
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of randomised patients who progress to complete study (feasibility to proceed to phase III will be defined as at least 60% completion of study intervention and measurements).[Day 6 and day 14]
- Secondary Outcome Measures
Name Time Method Australian Modified Karnofsky Performance Status [(baseline, day 6 and 14)<br>];Patient Global Impression of Change [(day 6 and day 14)<br>];Total opioid dose received per 24 hours in oral morphine equivalent, [baseline, Day 2 to Day 6, and day 14<br>];Overall survival from start of study<br>[Approximately six months or until data collection ceases.];Toxicity: Adverse Events (NCI-TCAEs)[Baseline, day1-6, and day 14.];Use of breakthrough opioid analgesia<br><br>[baseline, days 1-14.];Efficacy: Brief Pain Inventory average and worst pain score [baseline, days 2-6 and 14<br><br>];Quality of Life assessment (EORTC QLQ C15)<br>[baseline, day 6 and day 14 ]