Moderate to severe cancer pain Cancer Pain
Conditions
Interventions
Randomisation to receive oral morphine or oral oxycodone as first line Step 3 analgesics in moderate to severe cancer pain, and switch to alternative arm of study if lack of response to drug of initia
Sponsors
The Royal Marsden NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients must have a clinical or histological diagnosis of cancer 2. Patients whose pain is not controlled on Step 2 (weak opioid) analgesics (as defined by the WHO analgesic ladder) who clinically require a strong opioid 3. Patients must be over 18 years of age 4. Patients must be able to give written informed consent 5. Patients must be willing to undergo genetic screening
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 23/06/2011: 1. Patients with renal failure (1.5x ULN). These patients should be treated with alfentanil as per Palliative Care Clinical Guidelines 2. Patients must not currently be taking regular strong opioids 3. Patients requiring parenteral administration of opioids 4. Patients with predominantly incident pain 5. Patients with a clearly defined history of intolerance to morphine or oxycodone 6. Patients who are pregnant Previous exclusion criteria: 1. Patients with renal failure (1.5 x upper limit of normal [ULN]). These patients should be treated with alfentanil as per palliative care guidelines. 2. Patients must not have been taking regular Step 3 analgesics in the last month 3. Patients requiring parenteral administration of opioids 4. Patients with predominantly neuropathic pain 5. Patients with predominantly incident pain 6. Patients with a clearly defined history of intolerance to morphine or oxycodone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in response rate to morphine versus oxycodone. | — |
Secondary
| Measure | Time frame |
|---|---|
| Differences in levels of toxicity and differences in pre-specified clinical, laboratory, genetic, immunological and proteomic determinants between the two study groups. | — |
Countries
United Kingdom
Outcome results
None listed