CompletedPhase 2ACTRN12619000744156

Management of nausea in cancer patients – Nausea study 4 pilot

A randomised, controlled study of oral olanzapine versus oral haloperidol in patients with cancer and nausea not related to anticancer therapy (Nausea study 4 pilot)

Sponsor

The University of Technology Sydney

Enrollment

24 participants

Start Date

Aug 8, 2019

Study Type

Interventional

Conditions

Advanced Cancer Nausea

Summary

Many people with cancer experience chronic nausea that has a significant impact on their quality of life. Nausea (and vomiting) unrelated to anti-cancer treatment remains an important and under-researched health problem. To address this, a series of high quality randomised controlled trials (RCTs) have been performed to try and improve the evidence base. This is study 4 in the series which will compare the effect of anti-nausea medication: oral olanzapine and oral haloperidol, on management of nausea in cancer patients. Who is it for? You may be eligible to join this study if you are aged 18 and above, have been diagnosed with cancer, experiencing nausea. Study details: Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will receive Olanzapine (Zyprexa) once per day for three days. And participants in the second group will receive Haloperidol (Serenace) once per day for three days. Cost and effectiveness: Cost of each treatment will be assessed by collecting participant data at baseline, on exit, then weekly to an extended 7 day follow up period or death, whichever is sooner. Resource data to be collected will include health service utilisation and prognosis. Effectiveness of each treatment will be assessed by the use of the numerical rating scale. This research will provide new evidence to guide clinician choices of medications to better control nausea in patients with cancer.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria7

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 Criteria17

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)

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Interventions

This study is a 2 arm, randomised controlled study where participants with advanced cancer experiencing nausea (not related to anticancer therapy) will be randomised to receive either oral olanzapine

This study is a 2 arm, randomised controlled study where participants with advanced cancer experiencing nausea (not related to anticancer therapy) will be randomised to receive either oral olanzapine or haloperidol. Arm 1: Olanzapine (also known as Zyprexa®) Dose level 1: 2.5mg tablet orally once daily Dose level 2: 2.5mg tablet orally twice daily Treatment period: 3 x 24hours study period Arm 2: Haloperidol (also known as Serenace®) Dose level 1: 0.5mg tablet orally once daily Dose level 2: 0.5mg tablet orally twice daily Treatment period: 3 x 24hours study period The dose of trial medications can be increased once, to dose level 2, at 24 or 48 hours. The decision to increase dose level is primarily a clinical decision based on degree of response and toxicity. The pharmacy will maintain accountability records, in addition to the study allocation records. Metoclopramide 10mg (as required) 6-hourly orally or parenterally (subcutaneous or intravenous) to a maximum dose of 60mg/24 hours. Assessments for need for rescue doses will be according to normal ward (or community) practice. Rescue doses should be freely available and given regularly in those participants not responding to the medications. Domperidone 10-20mg 6-hourly orally is an acceptable alternative for those participants unable to tolerate metoclopramide. Domperidone cannot be given parenterally. The number of rescue doses given each 24 hours will be recorded and used to determine response status. No other antiemetic, regular and as required, is not allowed during the 3-day trial period. Any participants given non-trial antiemetics during the trial period will be withdrawn from study.