None listed
Conditions
Brief summary
This study aims to find out how achievable it is to find participants for a trial that involves cancer patients whom despite taking recommended pain relief medications continue to experience problems with pain management, and add either dexamethasone or placebo to their usual medications and evaluate the response. Who is it for? You may be eligible to join this study if you are aged greater than 18 years and continue to experience pain related to cancer or its treatment, despite taking recommended pain relief medications. Study details Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will receive daily injections of a steroid medication known as dexamethasone for 5 days. The injection will either be administered intravenously (i.e. directly into the vein) or subcutaneously (i.e. into the skin). Participants in the other group will receive daily saline injections instead. Saline is an inactive (placebo) treatment. Participants will not know which group they are in until the end of the study. All participants will be asked to complete a number of questionnaires over a period of 14 days in order to evaluate their pain levels and quality of life. Total opioid dose received, overall survival and the occurrence of any adverse events will also be recorded. Data collected from this study will help us determine how achievable it is to proceed to conduct a larger trial.
Interventions
Dexamethasone 8mgs parenteral, daily for five days (intravenous or subcutaneous) or placebo. Routine blood test prior to commencement. Return of syringes/study drug with patient diary.
Route of administration is determined by the participants current medical management. If they have intravenous access of any kind for routine care, the study drug will be given intravenously. All other participants will have the drug given subcutaneously through a subcutaneous butterfly set to minimise invasive a
Dexamethasone 8mgs parenteral, daily for five days (intravenous or subcutaneous) or placebo. Routine blood test prior to commencement. Return of syringes/study drug with patient diary. Route of administration is determined by the participants current medical management. If they have intravenous access of any kind for routine care, the study drug will be given intravenously. All other participants will have the drug given subcutaneously through a subcutaneous butterfly set to minimise invasive and more painful measures.
Sponsors
Mater Misericordiae Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed