The Preventative Role of Exogenous Melatonin Administration in Patients With Advanced Cancer Who Are at Risk of Delirium: a Feasibility Study
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|ClinicalTrials.gov Identifier: NCT02200172|
Recruitment Status : Completed
First Posted : July 25, 2014
Last Update Posted : July 19, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Other: Melatonin Other: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||December 2014|
|Primary Completion Date :||April 2016|
|Study Completion Date :||April 2016|
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.
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 Name: Sublingual placebo daily at 21.00 hours (±1 hour).
- 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.
- 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.
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
|Bruyère Continuing Care|
|Ottawa, Ontario, Canada, K1N 5C8|
|Principal Investigator:||Peter Lawlor, MB, MMedSc||Clinician Scientist, Bruyère Research Institute; Medical Director, Bruyère Continuing Care|