HALO Trial: Haloperidol vs Olanzapine in Hyperactive Delirium in Palliative Care Patients; A Multi-Centre, Randomised-Controlled Trial

Who is this study for? Patients with advanced cancer with hyperactive delirium
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Methods: The investigators will conduct a pragmatic, multi-centre, (hospital, inpatient hospice, community hospital) open-label randomised-controlled trial comparing the use of Haloperidol versus Olanzapine in advanced cancer or end-stage organ disease patients with hyperactive delirium. The primary outcome is the change in Richmond Agitation and Sedation Scale (RASS) scores among patients in each treatment group at 8 hours post-drug administration. The secondary outcome is the control of hyperactive delirium at 24, 48 and 72 hours using either Haloperidol or Olanzapine. The mean doses of Haloperidol and Olanzapine used as well as the volume of rescue Midazolam required as well as side-effects of the study medications, survival after enrolment into study will also be studied. 4. Significance to palliative care The results of this study will advance the knowledge of delirium management worldwide with regards to the efficacy of Haloperidol and Olanzapine in managing hyperactive delirium in patients with advanced cancer or end-stage organ disease. Haloperidol is used traditionally in palliative care for managing delirium. However, as a conventional anti-psychotic, it does cause extra-pyramidal side-effects. Olanzapine, a newer atypical anti-psychotic with a more favourable side-effect profile is being used increasingly in the control of delirium. These 2 commonly used drugs have never been compared head to head in a randomised-controlled, multi-centre study.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 99
Healthy Volunteers: f
View:

• Patients with advanced cancer or end-stage organ disease

• Age ≥ 21 years old

• Fulfil All Three Diagnosis of Delirium:

‣ Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) criteria for delirium

⁃ Memorial Delirium Assessment Scale (MDAS)©1996 \>/= 13

⁃ Richmond Agitation-Sedation Scale (RASS) Score +1 to +3

• Able to consume medications orally

• Prognosis \> 48 hrs (Clinician Estimate)

Locations
Other Locations
Singapore
Dover Park Hospice
RECRUITING
Singapore
St. Andrew's Community Hospital
RECRUITING
Singapore
Tan Tock Seng Hospital
RECRUITING
Singapore
Contact Information
Primary
Mervyn Koh
mervyn_koh@ttsh.com.sg
+6597678996
Backup
Allyn Hum
allyn_hum@ttsh.com.sg
+6581263205
Time Frame
Start Date: 2022-05-18
Estimated Completion Date: 2024-12
Participants
Target number of participants: 72
Treatments
Active_comparator: Haloperidol Arm
Haldol 2mg/ml oral solution
Active_comparator: Olanzapine Arm
Olanzapine Actavis 5mg orodispersible tablet
Related Therapeutic Areas
Sponsors
Leads: Tan Tock Seng Hospital

This content was sourced from clinicaltrials.gov