Melatonin vs. placebo for prevention of delirium in hospital in people with advanced cancer
Randomised, double-blind, placebo-controlled phase III trial of oral melatonin for the prevention of delirium in hospital in people with advanced cancer
University Technology Sydney
220 participants
Jul 19, 2017
Interventional
Conditions
Summary
The primary purpose of this trial is to evaluate the effectiveness of melatonin in preventing delirium in hospital inpatients with advanced cancer. Who is it for? You may be eligible to enrol in this trial if you are aged 18 or over and have been diagnosed with advanced cancer for which the intention of treatment is not to cure, and have been admitted to an acute or sub-acute inpatient hospital facility within the previous 48 hours. Study details All participants enrolled in this trial will be randomly allocated (by chance) to receive either melatonin tablets or placebo (sham) tablets, once per day at night time until delirium occurrence, discharge from the hospital facility, or for a maximum of 3 weeks after any acute medical issues with a delirium risk have been resolved. All participants will be asked to complete a number of questionnaires once per day for the duration of their melatonin/placebo treatment to evaluate levels of delirium and effects on sleep, and researchers will also review medical records to evaluate healthcare resource use. It is hoped that the findings from this trial will provide information on the efficacy of melatonin as a preventative treatment for delirium in advanced cancer inpatients.
Eligibility
Inclusion Criteria5
- Aged 18 years or older
- English speaking or availability of a health care interpreter.
- Diagnosis of advanced cancer (histological or clinical diagnosis) defined by the intent of treatment no longer being curative
- Admission to an acute or sub-acute inpatient facility
- Participant is able to give fully informed written consent
Exclusion Criteria13
- Inability to take medications orally
- Delirium on admission as defined the cut off score on the delirium rating scale DRS-R-98 of 17.75 or more indicative of delirium
- Australian Karnofsky Performance Status (AKPS) score less than 30 at the beginning of the study
- A known allergy to melatonin or placebo content
- Active seizure disorder defined as seizure within last one month, or seizure disorder not on anticonvulsants
- Concomitant cimetidine use (CYP2D Inhibitor increases melatonin levels by 1.7 fold)
- Current history alcohol abuse (alcohol reduces melatonin levels);
- In people taking warfarin, a markedly nontherapeutic international normalized ratio (less than 1 or greater than 4)
- Moderate to severe dementia as defined by clinical diagnosis of dementia and a Short Blessed Test (SBT) score equal or greater that 10
- Severe hepatic impairment (defined as bilirubin at least 2.5 times upper limit of normal; alkaline phosphatase, aspartate transaminase and/or alanine transaminase more than 3 times upper limit of normal clinically determined to be due to hepatic impairment)
- Current use of melatonin for other indication, melatonin use within last 14 days
- Currently taking agomelatine, or use of agomelatine in the past 7 days
- Pregnant or breastfeeding
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Interventions
Melatonin prolonged release 2mg oral tablet nightly commenced within 48 hours after hospital admission and continued until delirium occurrence, discharge, or for a maximum of 3 weeks after any acute medical issues imparting a delirium risk have been resolved. The intervention will be delivered at 20:00 hours. At each dose, the individually labelled bottle will be opened and the prescribed dose taken out. The clinical nurse will observe the participant while the participant swallows the tablet whole, and then record the administration in the medicine record.
Locations(11)
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ACTRN12616001618448