None listed
Conditions
Brief summary
This study aims to find out if a drug called Nozinan (methotrimeprazine) works better in treating nausea that is cancer related than the standard drug Haloperidol. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have cancer related nausea to a certain level of nausea that is not from cancer treatment. Study details Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will receive Nozinan tablets once daily (up to twice daily if necessary) for 3 days, whilst participants in the other group will receive Haloperidol tablets once daily (up to twice daily if necessary) for 3 days. Neither you nor the research team or Doctor will know which drug you will get. You will also have access to two other 'rescue' nausea medications as a back-up for your nausea. You will be required to fill out questionnaires related to your nausea/symptoms before the study drug starts, every 24 hrs after the drug is taken, when the study drug finishes, and for four weekly follow-ups. You can be an in-patient or an outpatient to complete this study.
Interventions
Patients will be randomized to receive either blinded encapsulated oral methotrimeprazine (6.25mg ) or oral haloperidol (1.5mg ) both given once daily (od), for three intervention days. All other regular antiemetics will be discontinued. Metoclopramide 10mg every 6 hours subcutaneous or oral (max dose 30mg/24hrs taken at any time during the intervention as long as it is 4 hours apart) will be available as a rescue antiemetic as well as Domperidone 10-20mg up to four times per day, per oral as an
Patients will be randomized to receive either blinded encapsulated oral methotrimeprazine (6.25mg ) or oral haloperidol (1.5mg ) both given once daily (od), for three intervention days. All other regular antiemetics will be discontinued. Metoclopramide 10mg every 6 hours subcutaneous or oral (max dose 30mg/24hrs taken at any time during the intervention as long as it is 4 hours apart) will be available as a rescue antiemetic as well as Domperidone 10-20mg up to four times per day, per oral as an alternative to metoclopramide (taken when needed during intervention period). In the absence of response at 24 hours or 48 hours, the dose of the study drug can be increased to twice daily (total daily dose 12.5mg methotrimeprazine or 3mg haloperidol). All study drug/bottles to be returned at completion of study or study withdrawal/exit.
Sponsors
Palliative Care Clinical Studies Collaborative (PaCCSC)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
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
Outcome results
None listed