ACTRN12610000481077.
Study name | The effectiveness of guideline‐driven antiemetic therapy versus single agent antiemetic therapy in patients with cancer and nausea not related to cancer therapy. A two‐stage trial of response to 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. |
Methods | Randomised Controlled Trial Multi‐centre, open‐label randomised parallel arm trial. Participants are randomised to active treatment arms 1 or 2. |
Participants | Patients with cancer and nausea not related to anticancer therapy. |
Interventions | Arm 1: targeted guideline‐driven antiemetic therapy dependent on presumed cause of nausea. Arm 2: haloperidol in a three‐step dose escalation schedule from 1mg over 24 hours to 3mg over 24 hours given orally or parenterally (subcutaneously). |
Outcomes | Primary outcome: response to treatment at 72 hours. Response defined as at least a two‐point improvement in average nausea score from baseline and final score less than 3 on an 11‐point numeric rating scale. |
Starting date | First enrolment 15 June 2010. |
Contact information | Professor Patsy Yates Head of School, Faculty of Health, School ‐ Nursing Queensland University of Technology, Brisbane QLD 4001 Australia |
Notes | Preliminary results of this study were published as a conference abstract in 2014 (see Yates 2010 secondary reference). |