The Preventative Role of Exogenous Melatonin Administration in Patients With Advanced Cancer Who Are at Risk of Delirium: a Feasibility Study
NCT ID: NCT02200172
Last Updated: 2016-07-19
Study Results
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Basic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2014-12-31
2016-04-30
Brief Summary
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Detailed Description
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Although sleep-wake cycle disturbance is not a core diagnostic criterion for delirium, studies of delirium in cancer patients have reported occurrence rates of 75-100%. This most likely reflects a circadian rhythm disturbance. Recent research suggests that giving melatonin to patients who are admitted to hospital may prevent them from developing delirium.
This feasibility study aims to inform a larger randomized, placebo-controlled, double blind, parallel-group, single-centre trial of an oral, daily administered single dose of melatonin to prevent delirium in patients with advanced cancer.
The study will be conducted on the 31-bed Palliative Care Unit (PCU), a university teaching unit, at Bruyère Continuing Care. The intervention consists of a single daily sublingually administered tablet of either 3mg non-animal synthetic source or placebo at 21.00 hours (±1 hour), starting on study day 1 and stopping on study day 28 of admission or earlier in the event of death or discharge. The study drug will be discontinued immediately if incident delirium occurs before day 28.
Throughout the trial, multiple dimensions of feasibility will be evaluated such as recruitment, retention and acceptability of study procedures.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Melatonin
A single daily sublingually administered tablet of 3mg non-animal synthetic source melatonin (immediate-release) at 21.00 hours (±1 hour), starting on Study Day 1 and stopping on Study Day 28 of admission or earlier in the event of death or discharge.
Melatonin
Sublingual 3mg non-animal synthetic source melatonin daily at 21.00 hours (±1 hour).
Placebo
A single daily sublingually administered tablet of placebo at 21.00 hours (±1 hour), starting on Study Day 1 and stopping on Study Day 28 of admission or earlier in the event of death or discharge.
Placebo
Interventions
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Melatonin
Sublingual 3mg non-animal synthetic source melatonin daily at 21.00 hours (±1 hour).
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Bruyère Health Research Institute.
OTHER
Responsible Party
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Principal Investigators
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Peter Lawlor, MB, MMedSc
Role: PRINCIPAL_INVESTIGATOR
Clinician Scientist, Bruyère Research Institute; Medical Director, Bruyère Continuing Care
Locations
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Bruyère Continuing Care
Ottawa, Ontario, Canada
Countries
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References
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Hanania M, Kitain E. Melatonin for treatment and prevention of postoperative delirium. Anesth Analg. 2002 Feb;94(2):338-9, table of contents. doi: 10.1097/00000539-200202000-00019.
Al-Aama T, Brymer C, Gutmanis I, Woolmore-Goodwin SM, Esbaugh J, Dasgupta M. Melatonin decreases delirium in elderly patients: a randomized, placebo-controlled trial. Int J Geriatr Psychiatry. 2011 Jul;26(7):687-94. doi: 10.1002/gps.2582. Epub 2010 Sep 15.
Hagen NA, Biondo PD, Brasher PM, Stiles CR. Formal feasibility studies in palliative care: why they are important and how to conduct them. J Pain Symptom Manage. 2011 Aug;42(2):278-89. doi: 10.1016/j.jpainsymman.2010.11.015. Epub 2011 Mar 27.
Siddiqi N, Stockdale R, Britton AM, Holmes J. Interventions for preventing delirium in hospitalised patients. Cochrane Database Syst Rev. 2007 Apr 18;(2):CD005563. doi: 10.1002/14651858.CD005563.pub2.
Tabet N, Howard R. Pharmacological treatment for the prevention of delirium: review of current evidence. Int J Geriatr Psychiatry. 2009 Oct;24(10):1037-44. doi: 10.1002/gps.2220.
Agar M, Lawlor P. Delirium in cancer patients: a focus on treatment-induced psychopathology. Curr Opin Oncol. 2008 Jul;20(4):360-6. doi: 10.1097/CCO.0b013e328302167d.
Lawlor PG, Fainsinger RL, Bruera ED. Delirium at the end of life: critical issues in clinical practice and research. JAMA. 2000 Nov 15;284(19):2427-9. doi: 10.1001/jama.284.19.2427. No abstract available.
Miyazaki T, Kuwano H, Kato H, Ando H, Kimura H, Inose T, Ohno T, Suzuki M, Nakajima M, Manda R, Fukuchi M, Tsukada K. Correlation between serum melatonin circadian rhythm and intensive care unit psychosis after thoracic esophagectomy. Surgery. 2003 Jun;133(6):662-8. doi: 10.1067/msy.2003.149.
Olofsson K, Alling C, Lundberg D, Malmros C. Abolished circadian rhythm of melatonin secretion in sedated and artificially ventilated intensive care patients. Acta Anaesthesiol Scand. 2004 Jul;48(6):679-84. doi: 10.1111/j.0001-5172.2004.00401.x.
de Jonghe A, van Munster BC, van Oosten HE, Goslings JC, Kloen P, van Rees C, Wolvius R, van Velde R, Levi MM, Korevaar JC, de Rooij SE; Amsterdam Delirium Study group. The effects of melatonin versus placebo on delirium in hip fracture patients: study protocol of a randomised, placebo-controlled, double blind trial. BMC Geriatr. 2011 Jul 5;11:34. doi: 10.1186/1471-2318-11-34.
de Jonghe A, Korevaar JC, van Munster BC, de Rooij SE. Effectiveness of melatonin treatment on circadian rhythm disturbances in dementia. Are there implications for delirium? A systematic review. Int J Geriatr Psychiatry. 2010 Dec;25(12):1201-8. doi: 10.1002/gps.2454.
Lawlor PG, McNamara-Kilian MT, MacDonald AR, Momoli F, Tierney S, Lacaze-Masmonteil N, Dasgupta M, Agar M, Pereira JL, Currow DC, Bush SH. Melatonin to prevent delirium in patients with advanced cancer: a double blind, parallel, randomized, controlled, feasibility trial. BMC Palliat Care. 2020 Oct 21;19(1):163. doi: 10.1186/s12904-020-00669-z.
Bush SH, Lacaze-Masmonteil N, McNamara-Kilian MT, MacDonald AR, Tierney S, Momoli F, Agar M, Currow DC, Lawlor PG. The preventative role of exogenous melatonin administration to patients with advanced cancer who are at risk of delirium: study protocol for a randomized controlled trial. Trials. 2016 Aug 11;17:399. doi: 10.1186/s13063-016-1525-8.
Related Links
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Bruyère Research Institute, Ottawa, Canada
Other Identifiers
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BRI-MELAT-2013
Identifier Type: -
Identifier Source: org_study_id
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