A two-stage trial of antiemetic therapy in patients with cancer and nausea not related to anticancer therapy.
Study 1: A randomised open label study of guideline–driven targeted antiemetic therapy versus single agent antiemetic therapy.
Study 2: A randomised controlled double blind study of levomepromazine or ondansetron versus placebo with rescue antiemetics (best supportive care) in patients with refractory nausea.
Funded by the National Health and Medical Research Council (NHMRC)
Sponsored by the Palliative Care Clinical Studies Collaborative (PaCCSC)
Prof Patsy Yates, School of Nursing, QUT
Prof Janet Hardy, Director of Palliative Care, Mater Health Services
Nausea in advanced cancer is a multifaceted problem. Recent systematic reviews have concluded that there is a paucity of evidence to support decisions about antiemetic therapy for patients with advanced cancer. A ‘mechanistic’ approach (where the decision to use a specific antiemetic drug depends on the aetiology of the nausea) has been shown to be effective in reducing nausea in uncontrolled studies. The empirical approach advocates the use of one drug irrespective of the cause of the nausea. This approach has also been shown to be effective. In some cases however, the nausea remains refractory to treatment despite multiple lines of treatment often in combination. Two drugs that may be potentially useful for treating refractory nausea in patients with advanced cancer are ondansetron and levomepromazine (methotrimeprazine). These drugs have not yet been rigorously evaluated in this setting and do not yet have a registered indication for use in palliative care. The primary aim of this study is to assess the efficacy of two drugs (levomepromazine and ondansetron) against placebo with rescue antiemetics (best supportive care (BSC) in all arms in patients with nausea that has been demonstrated to be refractory to standard treatment as defined in study 1 (protocol number 010/09) .
Further Information:
Contact: Janene Leslie (Study coordinator) Email: janene.leslie@qut.edu.au
Publications:
1. Glare P et al. Systematic review of the efficacy of antiemetics in the treatment of nausea in patients with far advanced cancer. Support Care Cancer 2004; 12:432-40.
2. Hardy J et al. A double-blind, randomised, parallel group, multinational, multicentre study comparing a single dose of ondansetron 24 mg p.o. with placebo and metoclopramide 10 mg t.d.s. p.o. in the treatment of opioid-induced nausea and emesis in cancer patients. Support Cancer Care 2002; 10: 231-236.
3. Stephenson J, Davies A. An assessment of aetiology-based guidelines for the management of nausea and vomiting in patients with advanced cancer. Support Care Cancer 2006; 14: 348-353.
4. Kennett A et al. An open study of methotrimeprazine in the management of nausea and vomiting in patients with advanced cancer. Support Cancer Care 2005; 13: 715-721.