None listed
Conditions
Brief summary
This study will determine the feasibility and acceptability of using melatonin for the prevention of delirium in patients with advanced cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have a diagnosis of advanced cancer defined by the intent of treatment being no longer curative. You need to also be an inpatient at a palliative care or oncology facility. Trial details Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in one group will take 2mg of melatonin by mouth every night for the duration of inpatient admission, and those in the other group will take a placebo (sham) treatment instead. Participants will not know which group they are in. Participants will be assessed during their admission to evaluate the efficacy of melatonin in preventing delirium events and to evaluate any effects on sleep quality, toxicity and other health outcomes.
Interventions
Oral, prolonged-release melatonin (2mg) every night for the duration of inpatient admission.
Sponsors
Flinders University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Diagnosis of advanced cancer defined by the intent of treatment being no longer curative; Admission to an acute or subacute inpatient palliative care or oncology facility; Capacity to give written informed consent; English speaking; Participant is capable of completing assessments and complying with the study procedures.
Exclusion criteria
Inability to communicate in English; Inability to take medications orally or via gastrostomy tube; Delirium on admission as defined by the cut-off score on DRS-98-R equal to or greater than 17.75 indicative of delirium; Australian Karnofsky Performance Status (AKPS) less than 31; Known allergy to melatonin or placebo content; Active seizure disorder defined as seizure within last one month, or seizure disorder not on anticonvulsants (due to pro-convulsive effect of melatonin in children and severe epilepsy); Concomitant cimetidine use (CYP2D Inhibitor increases melatonin plasma levels by 1.7 fold); Patients with a current history of abuse of alcohol (alcohol reduces melatonin levels); In people taking warfarin a markedly nontherapeutic international normalized ratio (INR) defined as less than 1 or more than 4 (due to melatonin both causing increase and decreased INR); Moderate to severe dementia as defined by clinical diagnosis of dementia and a Short Blessed Test (SBT) score of equal to or greater than 10; Current use of melatonin for other indication, or use of melatonin within last 14 days; Pregnancy or breastfeeding; Participants who have participated in a clinical study of a new chemical entity within the month prior to study entry.
Outcome results
None listed