A study for participants with cancer who experience ongoing nausea, not related to their treatment, despite taking standard and usual medications, that studies the effectiveness of oral methotrimeprazine versus oral haloperidol.
- Conditions
- Patients with cancer and nausea not related to anticancer treatment.Cancer - Any cancer
- Registration Number
- ACTRN12615000177550
- Lead Sponsor
- Palliative Care Clinical Studies Collaborative (PaCCSC)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 126
1. are 18 years or over
2. have a clinical diagnosis of cancer
3. 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)
4. are able to tolerate oral medications
5. are able to comply with all trial requirements
6. are able to provide fully informed consent
1. have nausea related to the treatment of cancer (i.e. surgery, chemotherapy, radiotherapy) within 5 days of anticancer therapy
2. 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)
3. are to undergo a procedure or intervention with the potential to affect nausea during the 3 day study period (eg chemotherapy or radiotherapy to a site likely to cause nausea)
4. have received methotrimeprazine or haloperidol at doses equivalent to dose level 1 per day within the previous 48 hours
5. have had uncontrolled nausea despite treatment with methotrimeprazine or haloperidol at study doses within the previous 2 weeks
6. if on corticosteroids, the dose has changed within 48 hours prior to study or is likely to change during the 3 day study period
7. have a definite contraindication to methotrimeprazine (severe hepatic impairment (LFTs above 5 x upper limit of normal, symptomatic postural hypotension, phenothiazine hypersensitivity, concurrent treatment with MAOIs, severe renal disease (eGFR less than 30), severe myocardial disease (clinician assessment))
8. have a definite contraindication to haloperidol (Parkinson’s disease, movement disorders, severe hepatic impairment)
9. documented congenital or acquired (drug induced#) QTc prolongation (QTc greater than 440sec in men and greater than 0.46sec in women, calculated manually as per Bazett’s formula) or factors that exacerbate QT prolongation ie untreated hypokalaemia, hypothyroidism or bradyarrythmias
10. uncontrolled epilepsy or glaucoma
11. concurrent treatment with monoamine oxidase inhibitors
12. have had a previous adverse reaction to the study medications
13. are pregnant or breastfeeding
14. have participated in a trial of a new clinical entity within the last 28 days
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response to treatment, at 72 hours from time of first study drug administration, defined as more than or equal to a 2 point improvement from baseline for average nausea over the preceding 24 hours on an 11 point nausea NRS [Response to treatment at 72 hours]
- Secondary Outcome Measures
Name Time Method