Management of nausea in cancer patients – Nausea study 4 pilot

Phase 2

Recruiting

• Conditions: ausea; Advanced Cancer; Nausea; Cancer - Any cancer

• Registration Number: ACTRN12619000744156
• Lead Sponsor: The University of Technology Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-20
• Last Update Posted: 26 September 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 24

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 able to tolerate oral medications
- 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) within 5 days of anticancer therapy
-have nausea for which a specific antiemetic is indicated and randomisation to study medications alone would not be appropriate (dexamethasone for acutely raised ICP, 5HT3 antagonists for chemotherapy induced nausea/vomiting)
-are to undergo a procedure or intervention with the potential to affect nausea during the 3 day study period (e.g. chemotherapy or radiotherapy to a site likely to cause nausea)
-have received ondansetron, olanzapine or haloperidol at doses equivalent to dose level 1 per day within the previous 48 hours
-have had uncontrolled nausea despite treatment with ondansetron, olanzapine or haloperidol at study doses within the previous 2 weeks
-if on corticosteroids, the dose has changed within 48 hours prior to study or is likely to change during the 3 day study period
-have a definite contraindication to haloperidol (Parkinson’s disease, movement disorders, severe hepatic impairment*)
-documented congenital or acquired (drug induced#) QTc prolongation (QTc>440sec in men and >0.46sec in women, calculated manually as per Bazett’s formula^) or factors that exacerbate QT prolongation i.e. untreated hypokalaemia, hypothyroidism or bradyarrythmias
-uncontrolled epilepsy or glaucoma
-concurrent treatment with monoamine oxidase inhibitors
-have had a previous adverse reaction to the study medications
-are pregnant or breastfeeding
-have participated in a trial of a new clinical entity within the last 28 days

* this applies to AST, ALT or bilirubin but not to ALP or GGT
# see appendix for drugs with the potential to prolong QT
^ QTc=QT interval/square root of the RR interval (in sec)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The effectiveness of oral olanzapine versus oral haloperidol in improving the management of nausea in patients with cancer and nausea not related to anticancer therapy. A response would be a greater than or equal to 2 point improvement from baseline for average nausea over the preceding 24 hours on an 11 point nausea NRS.[Eligibility, baseline, Day 1, 2 and 3 of intervention and at follow up for week 1, 2, 3 and 4. ]