The effectiveness of guideline driven antiemetic therapy versus single agent antiemetic therapy in patients with cancer and nausea not related to cancer therapy.

Not Applicable

Completed

• Conditions: ausea in the setting of advanced cancer not related to anticancer therapy; Nausea in the setting of advanced cancer not related to anticancer therapy; Cancer - Other cancer types

• Registration Number: ACTRN12610000481077
• Lead Sponsor: Professor Patsy Yates

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-06-11
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 216

Inclusion Criteria

Patients who: are 18 years or over, have a clinical diagnosis of cancer, have nausea with an average score over the last 24 hours of greater than or equal to 3 on an 11 point numerical rating scale (NRS) anchored at 0 (no nausea) and 10 (worst possible nausea), are not currently receiving antiemetics or are already receiving antiemetics but these are inappropriate as defined by the antiemetic guidelines or are at a suboptimal dose, are able to comply with all trial requirements, are able to provide fully informed consent

Exclusion Criteria

Patients who: have nausea related to the treatment of cancer (i.e. surgery, chemotherapy, radiotherapy) where acute treatment with 5HT3 antagonists is indicated (i.e. within 5 days of anticancer therapy), have nausea for which a specific antiemetic is indicated and randomisation to haloperidol would not be appropriate (e.g. dexamethasone for acutely raised ICP), have undergone a procedure or intervention with the potential to affect nausea within 2 days prior to study or are likely to undergo a procedure or intervention with the potential to affect nausea during the 3 day study period, if on corticosteroids, the dose has changed within 48 hours prior to study, have a definite contraindication to any of the drugs listed in the guidelines (e.g. Parkinson’s disease, QTc prolongation on most recent ECG (>450msecs in men, >470msecs in women), uncontrolled seizures), have had a prior serious adverse event following use of any of the drugs listed in the guidelines (e.g. dystonic reaction, neuroleptic malignant syndrome), are pregnant or breastfeeding

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response to treatment at 72 hours. Response is defined as an improvement of at least two points in average nausea score from baseline and final score less than 3, measured for the previous 24 hours on an 11-point (0-10) numeric rating scale (NRS).[Average nausea: Baseline, 24, 48 and 72 hours after first study antiemetic administered<br>Response: At 24, 48 and 72 hours after first study antiemetic administered.]