To determine the feasibility of conducting a study of oral dexamethasone at a dose of 8mg daily in conjunction with opioids and standard adjuvant therapy, in the management of uncontrolled pain related to cancer or its treatment.
- Conditions
- Cancer painPalliative careCancer - Any cancer
- Registration Number
- ACTRN12615001336572
- Lead Sponsor
- Palliative Care Clinical Studies Collaborative
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 20
Age greater than 18 years
Pain related to cancer or its treatment
Brief Pain Inventory form (BPI-SF) average pain score >= 3/10 in the previous 24 hours
No increase in baseline opioid dose or co-analgesics within 48 hours before study entry, or planned increase during the study
Participant is capable of completing assessments and complying with the study procedures
Patients currently taking corticosteroids or who have taken corticosteroids within the previous seven days
Previous adverse reaction to dexamethasone
Patient unable to swallow oral medications
Patients scheduled to receive radiotherapy for pain or commencing a new chemotherapy/targeted therapy/hormonal therapy or other therapies/intervention if there is a realistic expectation of that therapy affecting pain
Any patient following major surgery where wound-healing is still occurring
Patients with clinician assessed unstable diabetes mellitus
Any patient with recent upper gastrointestinal bleeding or uncontrolled gastro-oesophageal reflux disease
Medically assessed history of systolic blood pressure >= 180 mmHg and/or dystolic blood pressure >= 110 mmHg, uncontrolled cardiac failure, marked fluid retention, acute sepsis
Patients with systemic fungal infections or recent vaccination with live virus
Patients with documented history of bipolar disorder, schizophrenia or severe anxiety or depression. Patients with evidence of psychosis or significant anxiety at time of trial commencement
Patients currently taking Non-steroidal Anti-inflammatory Drugs (NSAIDS) or who have taken NSAIDS within 3 days of trial commencement
Women who are pregnant or lactating. Patients at risk of pregnancy must have appropriate and effective contraceptive in place (or appropriate advice from their doctor regarding appropriate birth control)
Patients who have participated in a clinical study of a new chemical entity within the last month, prior to study entry
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary purpose of this pilot study is to assess feasibility. The co-primary feasibility outcomes will be: 1) enrollment of 20 patients across four sites in six months, and 2) at least 60% of enrolled patients progressing to study completion.[6 months after commencement of trial]
- Secondary Outcome Measures
Name Time Method