Feasibility of Prophylactic Haldol to Prevent Delirium in Cancer Patients (PHDC)

This research study proposes to conduct an open label, feasibility study administering prophylactic oral haldol to patients undergoing a hematopoietic stem cell transplant (HSCT).

The study will address the following research aims: 1) To demonstrate the feasibility of enrolling HSCT patients in a prophylactic medication trial, 2) To determine the tolerability of oral haldol in HSCT patients and 2) To compare rates of delirium in HSCT patients who receive prophylactic haldol with an untreated historical control group.

Study Overview

• Status: Completed
• Conditions: Delirium; Stem Cell Transplant Complications
• Intervention / Treatment: Drug: Haldol

Detailed Description

This is an open label, safety & feasibility, clinical drug trial. We will use historical controls from previous research with bone marrow transplant patients and delirium incidence at University of Iowa Hospitals and Clinics (UIHC) to evaluate the efficacy of prophylactic Haldol in the prevention of delirium. This study will recruit adult cancer patients undergoing hematopoietic stem cell transplant (HSCT) at UIHC.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The participant must undergo an autologous or allogeneic bone marrow or stem cell transplant
• The participant is 18 years of age or older
• The participant provides written consent

Exclusion Criteria:

• The participant has a QTc of >450 msec at the time of enrollment
• The participant used any antipsychotic medications within the last 30 days
• The participant has any significant allergies or past intolerance to Haloperidol
• The participant has a history of major neurological, metabolic, psychiatric, or cardiovascular disease, cerebrovascular event, or substance abuse
• The participant has a history of mental retardation or learning disability that, at the discretion of the investigator, could affect their ability to complete study assessments.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral Haldol in patients undergoing HSCT; Prior to stem cell transplant participants will receive 5mg of liquid or pill form, oral Haldol. Every other day visits will take place following the first administration of the study drug until 14 days after the transplant.	Drug: Haldol; Other Names: haloperidol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side Effects and Tolerability of Haldol in Patients With Undergoing Hematopoietic Stem Cell Transplant	Categorize and quantify adverse events from start of drug (day 1) to end of study drug per (CTCAE) version 4.0	Daily, up to 14 days following transplant

Collaborators and Investigators

• Sponsor: Michelle Weckmann
• Collaborators: American Cancer Society, Inc.
• Investigators: Principal Investigator: Michelle Weckmann, MD, University of Iowa

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2011
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: March 29, 2018
• First Submitted That Met QC Criteria: March 29, 2018
• First Posted (Actual): April 5, 2018

Study Record Updates

• Last Update Posted (Actual): May 22, 2018
• Last Update Submitted That Met QC Criteria: April 22, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Dopamine Agents; Dopamine Antagonists; Anti-Dyskinesia Agents; Haloperidol
• Other Study ID Numbers: 201107736

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No