Melatonin vs. placebo for prevention of delirium in hospital in people with advanced cancer

Phase 3

Completed

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

• Registration Number: ACTRN12616001618448
• Lead Sponsor: niversity Technology Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-23
• Study Completion: 2021-01-12
• Last Update Posted: 13 December 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 221

Inclusion Criteria

Aged 18 years or older
- English speaking or availability of a health care interpreter.
- Diagnosis of advanced cancer (histological or clinical diagnosis) defined by the intent of treatment no longer being curative
- Admission to an acute or sub-acute inpatient facility
- Participant is able to give fully informed written consent

Exclusion Criteria

- Inability to take medications orally
- Delirium on admission as defined the cut off score on the delirium rating scale DRS-R-98 of 17.75 or more indicative of delirium
- Australian Karnofsky Performance Status (AKPS) score less than 30 at the beginning of the study
- A known allergy to melatonin or placebo content
- Active seizure disorder defined as seizure within last one month, or seizure disorder not on anticonvulsants
- Concomitant cimetidine use (CYP2D Inhibitor increases melatonin levels by 1.7 fold)
- Current history alcohol abuse (alcohol reduces melatonin levels);
- In people taking warfarin, a markedly nontherapeutic international normalized ratio (less than 1 or greater than 4)
- Moderate to severe dementia as defined by clinical diagnosis of dementia and a Short Blessed Test (SBT) score equal or greater that 10
- Severe hepatic impairment (defined as bilirubin at least 2.5 times upper limit of normal; alkaline phosphatase, aspartate transaminase and/or alanine transaminase more than 3 times upper limit of normal clinically determined to be due to hepatic impairment)
- Current use of melatonin for other indication, melatonin use within last 14 days
- Currently taking agomelatine, or use of agomelatine in the past 7 days
- Pregnant or breastfeeding

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of delirium-free days (which occur before delirium onset for any participant who develops delirium). <br>For each participant, delirium screening will occur every 8 hours on each of the three 8-hour shifts by the ward nurses, using the Nursing Delirium Screening Scale (NuDESC). Participants scoring 2 or higher in the NuDESC will be assessed with The Delirium Rating Scale – Revised 98 (DRS-R-98) to confirm delirium presence and delirium severity.[From within 48 hours of hospital admission, until delirium occurrence, discharge or for a maximum of three weeks if patient remains in hospital after any acute medical issues imparting a delirium risk have been resolved]