Cancer Clinical Trial
Official title:
The Preventative Role of Exogenous Melatonin Administration in Patients With Advanced Cancer Who Are at Risk of Delirium: a Feasibility Study Prior to a Larger Randomized Controlled Trial
Verified date | July 2016 |
Source | Bruyere Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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 prevent delirium in patients with advanced cancer.
Status | Completed |
Enrollment | 60 |
Est. completion date | April 2016 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Canada | Bruyère Continuing Care | Ottawa | Ontario |
Lead Sponsor | Collaborator |
---|---|
Bruyere Research Institute |
Canada,
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. Review. — View Citation
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. Erratum in: Int J Geriatr Psychiatry. 2014 May;29(5):550. — View Citation
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. Review. — View Citation
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. — View Citation
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. Review. — View Citation
Hanania M, Kitain E. Melatonin for treatment and prevention of postoperative delirium. Anesth Analg. 2002 Feb;94(2):338-9, table of contents. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Siddiqi N, Stockdale R, Britton AM, Holmes J. Interventions for preventing delirium in hospitalised patients. Cochrane Database Syst Rev. 2007 Apr 18;(2):CD005563. Review. Update in: Cochrane Database Syst Rev. 2016;3:CD005563. — View Citation
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. Review. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to first onset of delirium for participants receiving active comparator versus placebo | Preliminary data will help determine the appropriateness of this outcome measure in a larger trial. | 8 months | No |
Primary | Number of times the blinding on the trial product is broken. | This number will indicate any further need for research team training. | 8 months | No |
Primary | Recruitment and retention rates | Recruitment and retention rates will determine if a larger trial with the same design will allow for a sufficient number of participants. | 8 months | No |
Primary | Frequency of protocol violation | The frequency of protocol violations will indicate if a larger trial with the same design can be implemented in a palliative care setting or require modification. | 8 months | No |
Primary | Number of unsolicited positive versus negative comments from participants, families, and Palliative Care Unit staff | Comments that are voluntarily provided will show whether the trial is acceptable to participants, families, Palliative Care Unit staff. | 8 months | No |
Secondary | Predisposing and precipitating risks form completion rate | Predisposing and precipitating factors will be collected on trial forms throughout the trial. The feasibility of collecting this data on the Palliative Care Unit will be measured by form completion rates. | 8 months | No |
Secondary | Number of participants with serious adverse events related to the active comparator | To assess the safety of the proposed intervention in this palliative care population will be assessed on an ongoing basis. | Participants will be followed for the duration of trial product administration plus 2 days for an expected total of 30 days | Yes |
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