A multi-centre, randomised, phase IV study to compare the efficacy of oxycodone/naloxone verses oxycodone prolonged release tablets in patients with advanced cancer
- Conditions
- cancer related painCancer - Any cancer
- Registration Number
- ACTRN12619001282178
- Lead Sponsor
- Peter MacCallum Cancer Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 37
1. Patient has provided written informed consent
2. Aged 18 years or older at the time of informed consent
3. Metastatic (Stage IV) or unresectable solid tumour or haematological malignancy
4. Patient has moderate to severe cancer-related pain defined as a numeric pain rating score of greater than or equal to 4 requiring commencement of Oxy PR 20-160mg per day or OXN PR 20/10 – 160/80mg per day either as first prolonged release opioid or switched from a different opioid, as determined by the investigator
5. Patients must have adequate organ function within 14 days of randomisation:
Defined by:
- Serum alanine aminotransferase less than 2.5 x upper limit of normal (ULN) and/or serum bilirubin less than 2.5 x ULN
- Serum albumin greater than or equal to 20g/L
- Estimated Glomerular Filtration Rate greater than or equal to 50mL/min (using CKD-EPI calculation)
6. Able to swallow oral medications
7. Able to complete study assessments
8. Has a life expectancy of at least 12 weeks
1.Patients with known liver metastasis
2.Clinically significant gastrointestinal disease including inflammatory bowel disease, intestinal obstruction or pseudo-obstruction, active diverticular disease, gastrointestinal haemorrhage, history of bowel perforation, history of ischaemic colitis
3.New chemotherapy or immunotherapy treatment starting within 14 days prior to randomisation
4.Radiotherapy to any abdominal area or site of pain within 4 weeks of randomisation
5.Enrolment on another clinical trial with an investigational agent for pain within 30 days of randomisation. (Enrolment in other non-pain investigational studies during this study is permitted, including chemotherapy and immunotherapy trials)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is to measure average pain over last 24 hours as measured by the BPI-SF at each time point taken over a 5-week period.<br><br>[The primary time point is 5 weeks. The outcome will be assessed at Week 0, 1, 3 and 5.]
- Secondary Outcome Measures
Name Time Method Degree of constipation as measured by the Bowel Function Index<br><br>[Measured every two weeks for 11 weeks. week 0, 1, 3, 5, 7, 9 and 11.];Quality of life, including nausea, vomiting, diarrhoea, appetite, functional activity, breathlessness, insomnia, fatigue, mood, memory, as measured by the EORTC-QLQ-C30[Measured every two weeks for 11 weeks. Week 0, 1, 3, 5, 7,9 and 11.];To measure the total daily dose of rescue analgesia as measured by patient medication diary[Every two weeks for 11 weeks. Week 0, 1, 3, 5, 7,9 and 11.];To measure total dose of study medication as measured by pill count or medication diary[Every two weeks commencing at week 1, followed by week 3, 5, 7, 9 and 11];To measure total laxative dose over a 5-week period[Every two weeks for 11 weeks. Commencing at Week 0, Followed by 1,3 ,5, 7, 9 and 11]