Haloperidol With or Without Chlorpromazine in Treating Delirium in Patients With Advanced, Metastatic, or Recurrent Cancer

Phase 2/3 Active not recruiting 70 enrolled M.D. Anderson Cancer Center National Cancer Institute (NCI) · collab National Institute of Nursing Research (NINR) · collab National Institutes of Health (NIH) · collab

RandomizedParallel-groupTriple-blindSupportive care

Summary

This randomized phase II/III trial studies how well haloperidol with or without chlorpromazine works in treating delirium in patients with cancer that has spread to other parts of the body or has come back. Haloperidol and chlorpromazine may control the symptoms of delirium (loss of contact with reality) in patients with cancer.

Timeline

Start: 2017-06-05
Primary completion: 2021-06-05
Completion: 2027-06-30

Outcome

Missed primary endpoint

registry Escalation Group vs Rotation Group vs Combination Group; p = 0.71; Wilcoxon Rank Sum Test NCT03021486 ↗

paper with no difference among groups (p=0·71). PMID 32479786 ↗

Publications

Hui D, De La Rosa A, Wilson A, Nguyen T, Wu J, Delgado-Guay M, Azhar A, Arthur J, Epner D, Haider A, De La Cruz M, Heung Y, Tanco K, Dalal S, Reddy A, Williams J, Amin S, Armstrong TS, Breitbart W, Bruera E. Neuroleptic strategies for terminal agitation in patients with cancer and delirium at an acute palliative care unit: a single-centre, double-blind, parallel-group, randomised trial. Lancet Oncol. 2020 Jul;21(7):989-998. doi: 10.1016/S1470-2045(20)30307-7. Epub 2020 May 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Chlorpromazine	Small molecule	12.5 mg	Intravenous
Subject	Chlorpromazine	Small molecule	25 mg	Intravenous
Subject	Haloperidol	Other / unclassified	1 mg	Intravenous
Subject	Haloperidol	Other / unclassified	2 mg	Intravenous