Melatonin versus placebo for prevention of delirium in inpatients with advanced cancer

Phase 2

Completed

• Conditions: Advanced cancer; Neurological - Other neurological disorders; Delirium; Cancer - Any cancer

• Registration Number: ACTRN12612000931875
• Lead Sponsor: Flinders University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-31
• Study Completion: 2015-03-30
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Diagnosis of advanced cancer defined by the intent of treatment being no longer curative;

Admission to an acute or subacute inpatient palliative care or oncology facility;

Capacity to give written informed consent;

English speaking;

Participant is capable of completing assessments and complying with the study procedures.

Exclusion Criteria

Inability to communicate in English;

Inability to take medications orally or via gastrostomy tube;

Delirium on admission as defined by the cut-off score on DRS-98-R equal to or greater than 17.75 indicative of delirium;

Australian Karnofsky Performance Status (AKPS) less than 31;

Known allergy to melatonin or placebo content;

Active seizure disorder defined as seizure within last one month, or seizure disorder not on anticonvulsants (due to pro-convulsive effect of melatonin in children and severe epilepsy);

Concomitant cimetidine use (CYP2D Inhibitor increases melatonin plasma levels by 1.7 fold);

Patients with a current history of abuse of alcohol (alcohol reduces melatonin levels);

In people taking warfarin a markedly nontherapeutic international normalized ratio (INR) defined as less than 1 or more than 4 (due to melatonin both causing increase and decreased INR);

Moderate to severe dementia as defined by clinical diagnosis of dementia and a Short Blessed Test (SBT) score of equal to or greater than 10;

Current use of melatonin for other indication, or use of melatonin within last 14 days;

Pregnancy or breastfeeding;

Participants who have participated in a clinical study of a new chemical entity within the month prior to study entry.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of eligible patients screened who progress to be randomised and complete study intervention[ Discharge or death]