ENhANCE trial protocol: A multi-centre, randomised, phase IV trial comparing the efficacy of oxycodone/naloxone prolonged release (OXN PR) versus oxycodone prolonged release (Oxy PR) tablets in patients with advanced cancer
- Author(s)
- Wong, AK; Grobler, A; Le, B;
- Journal Title
- Contemporary Clinical Trials Communications
- Publication Type
- Protocol
- Abstract
- BACKGROUND: Oxycodone is a frequently used opioid in cancer. Opioid-induced constipation (OIC) is common. Oxycodone/Naloxone Prolonged Release (OXN PR) contains naloxone, which mitigates OIC. Trials have either focused on non-cancer pain, or conducted before significant experience of using OXN PR. This trial aims to: demonstrate (1) analgesic equivalence between OXN PR and Oxycodone Prolonged Release (Oxy PR), and (2) superiority of constipation outcomes in OXN PR compared to Oxy PR in cancer pain. Unlike other trials, it will only include patients with at least moderate pain scores (>/=4/10), allow usual laxatives, and exclude potential liver dysfunction. METHODS: This is a multi-centre, open-label, randomised, phase IV study of OXN PR vs Oxy PR in patients with cancer-related pain. The primary outcome is pain difference on Brief Pain Inventory-Short Form (BPI-SF) at 5 weeks. Secondary outcomes are comparison of other pain outcomes (BPI-SF) and neuropathic pain measures (Leeds Assessment of Neuropathic Symptoms & Signs (S-LANNS)), constipation (Bowel Function Index (BFI)), quality of life (EORTC-QLQ-C30), rescue analgesia use, total opioid dose, and total laxative dose over 5 weeks. CONCLUSION: The comparison of analgesic efficacy between both arms, and superiority of constipation in the OXN PR arm will add new knowledge on the comparisons of both agents, and oxycodone independently. This trial will extend knowledge of the effectiveness, safety, and adverse effect profiles of both drugs in terms of pain, constipation, quality of life outcomes for patients with cancer pain, and provide clinicians with high quality data to guide decision making. TRIAL REGISTRATION: Name of the registry: ANZCTR. TRIAL REGISTRATION NUMBER: ACTRN12619001282178. DATE OF REGISTRATION: 17/09/2019. URL OF TRIAL REGISTRY RECORD: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377673&isReview=trueProtocol version 2.1_28 August 2020.
- Keywords
- Analgesics; BFI, Bowel Function Index; BPI - SF, Brief Pain Inventory - Short Form; CKD-EPI, Chronic Kidney Disease Epidemiology Collaboration calculation; Constipation; EORTC QLQ-C30, European Organisation for Research and Treatment of Cancer Quality; of Life Questionnaire; GEE, Generalised Estimating Equations; ITT, Intention To Treat; Neoplasms; OIC, opioid-induced constipation; OXN PR, oxycodone/naloxone prolonged release; Opioid; Oxy PR, oxycodone prolonged release; PRO CoMiDa, Patient Reported Outcome Completion and Missing Data Checklist; PRO, Patient Reported Outcome; Pain; Palliative care; S-LANSS, Leeds Assessment of Neuropathic Symptoms & Signs
- Department(s)
- Palliative Care
- PubMed ID
- 36407843
- Publisher's Version
- https://doi.org/10.1016/j.conctc.2022.101036
- Open Access at Publisher's Site
https://doi.org/10.1016/j.conctc.2022.101036- Terms of Use/Rights Notice
- Refer to copyright notice on published article.
Creation Date: 2025-05-16 01:14:57
Last Modified: 2025-05-16 01:16:07