ACTRN12615000177550.

Study name	A randomised, controlled, double blind study of oral methotrimeprazine versus oral haloperidol in patients with cancer and nausea not related to anticancer therapy (Nausea study 3), to compare the effectiveness of oral methotrimeprazine versus oral haloperidol in improving the management of nausea in patients with cancer and nausea not related to anticancer therapy.
Methods	Randomised controlled trial.
Participants	Patients with cancer and nausea not related to anticancer therapy, with nausea severity of at least 3 on an 11 point numeric rating scale (0 no nausea to 10 worst possible nausea).
Interventions	Blinded encapsulated oral methotrimeprazine (6.25mg) or haloperidol (1.5mg) given once daily for three intervention days. If no response at 24 or 48 hours, the dose of the study drug can be increased to twice daily. Rescue medication of metoclopramide or domperidone will be available.
Outcomes	Primary outcome: response to treatment at 72 hours from first study drug administration. Response defined as more than or equal to a two point improvement from baseline for average nausea over the preceding 24 hours on an 11 point numeric rating scale. Secondary outcomes: best nausea score over the preceding 24 hours; complete response (defined as at least two‐point improvement from baseline and a score of less than 3 for average nausea over preceding 24 hours, on 0 to 10 numeric rating scale; response; number of episodes of vomiting, not including retching; number of rescue antiemetic doses; toxicity.
Starting date	First enrolment 02 March 2015
Contact information	Prof Janet R Hardy, Director of Palliative Care Mater Health Services, Raymond Terrace, South Brisbane QLD 4101 Australia +617 31632775 janet.hardy@mater.org.au
Notes	http://www.anzctr.org.au/ACTRN12615000177550.aspx