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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

NCT02200172 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-07-19

No results posted yet for this study

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 prevent delirium in patients with advanced cancer.

Conditions

Interventions

OTHER

Melatonin

Sublingual 3mg non-animal synthetic source melatonin daily at 21.00 hours (±1 hour).

OTHER

Placebo

Sponsors & Collaborators

  • Bruyère Health Research Institute.

    lead OTHER

Principal Investigators

  • Peter Lawlor, MB, MMedSc · Clinician Scientist, Bruyère Research Institute; Medical Director, Bruyère Continuing Care

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02200172 on ClinicalTrials.gov