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Trial record 1 of 1 for:    NCT02200172
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The Preventative Role of Exogenous Melatonin Administration in Patients With Advanced Cancer Who Are at Risk of Delirium: a Feasibility Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02200172
First Posted: July 25, 2014
Last Update Posted: July 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bruyere Research Institute
  Purpose
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.

Condition Intervention Phase
Cancer Other: Melatonin Other: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Bruyere Research Institute:

Primary Outcome Measures:
  • Time to first onset of delirium for participants receiving active comparator versus placebo [ Time Frame: 8 months ]
    Preliminary data will help determine the appropriateness of this outcome measure in a larger trial.

  • Number of times the blinding on the trial product is broken. [ Time Frame: 8 months ]
    This number will indicate any further need for research team training.

  • Recruitment and retention rates [ Time Frame: 8 months ]
    Recruitment and retention rates will determine if a larger trial with the same design will allow for a sufficient number of participants.

  • Frequency of protocol violation [ Time Frame: 8 months ]
    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.

  • Number of unsolicited positive versus negative comments from participants, families, and Palliative Care Unit staff [ Time Frame: 8 months ]
    Comments that are voluntarily provided will show whether the trial is acceptable to participants, families, Palliative Care Unit staff.


Secondary Outcome Measures:
  • Predisposing and precipitating risks form completion rate [ Time Frame: 8 months ]
    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.

  • Number of participants with serious adverse events related to the active comparator [ Time Frame: Participants will be followed for the duration of trial product administration plus 2 days for an expected total of 30 days ]
    To assess the safety of the proposed intervention in this palliative care population will be assessed on an ongoing basis.


Enrollment: 60
Study Start Date: December 2014
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Other: Melatonin
Sublingual 3mg non-animal synthetic source melatonin daily at 21.00 hours (±1 hour).
Placebo Comparator: 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.
Other: Placebo
Other Name: Sublingual placebo daily at 21.00 hours (±1 hour).

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 most importantly in levels of patient and family distress. Inpatient palliative care is delivered in stand-alone hospice units and increasingly in designated units in acute care hospitals, where delirium occurrence rates of over 80% have been reported in the last hours and days before death. Most patients in these units have a cancer diagnosis. Given the increasing elderly proportion of the population, and that cancer is predominantly a disease of the elderly, there is a pivotal need to develop primary, secondary and tertiary preventative strategies for delirium in these patients.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02200172


Locations
Canada, Ontario
Bruyère Continuing Care
Ottawa, Ontario, Canada, K1N 5C8
Sponsors and Collaborators
Bruyere Research Institute
Investigators
Principal Investigator: Peter Lawlor, MB, MMedSc Clinician Scientist, Bruyère Research Institute; Medical Director, Bruyère Continuing Care
  More Information

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bruyere Research Institute
ClinicalTrials.gov Identifier: NCT02200172     History of Changes
Other Study ID Numbers: BRI-MELAT-2013
First Submitted: July 21, 2014
First Posted: July 25, 2014
Last Update Posted: July 19, 2016
Last Verified: July 2016

Keywords provided by Bruyere Research Institute:
Cancer
Melatonin
Delirium
Feasibility Studies
Palliative Care

Additional relevant MeSH terms:
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants