Status:
COMPLETED
The Preventative Role of Exogenous Melatonin Administration in Patients With Advanced Cancer Who Are at Risk of Delirium: a Feasibility Study
Lead Sponsor:
Bruyère Health Research Institute.
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this feasibility study is to inform a larger randomized, placebo-controlled, double blind, parallel-group, single-centre trial of an oral, daily administered single dose of melatonin to...
Detailed Description
Delirium is a very common and distressing neuropsychiatric syndrome in palliative care and a variety of other settings. It is associated with increases in morbidity, mortality, health care costs and m...
Eligibility Criteria
Inclusion
- Males and females ≥ 18 years
- Cancer diagnosis
- Admitted to Palliative Care Unit
- English speaking
- Cognitive capacity to give informed consent or substitute decision maker is accessible to provide consent
- Palliative Performance Scale ≥ 30% at the time of consent
Exclusion
- Delirium present on admission (assessed clinically with the CAM)
- Known psychotic disorder other than dementia
- Inability to take medications sublingually or via gastrostomy tube
- Known allergy to melatonin or placebo content
- Use of melatonin within the two weeks preceding admission
- Patient on warfarin treatment or other oral anticoagulant
- Communication problems that cannot be accommodated, including deafness, tracheostomy, aphasia, dysarthria or emotional distress
- On other investigational agents or treatments
- Pregnancy or lactation
- Severe visual impairment or designated legally blind
- Immunosuppressant medication use in the context of autoimmune disease or post organ transplantation
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02200172
Start Date
December 1 2014
End Date
April 1 2016
Last Update
July 19 2016
Active Locations (1)
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1
Bruyère Continuing Care
Ottawa, Ontario, Canada, K1N 5C8