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

• ClinicalTrials.gov Identifier: NCT03489551
• Recruitment Status: Completed
• First Posted: April 5, 2018
• Results First Posted: May 22, 2018
• Last Update Posted: May 22, 2018
• Sponsor: Michelle Weckmann
• Collaborator: American Cancer Society, Inc.
• Information provided by (Responsible Party): Michelle Weckmann, University of Iowa

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Stem Cell Transplant Complications; Delirium	Drug: Haldol	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 17 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Feasibility of Prophylactic Haldol to Prevent Delirium in Cancer Patients
• Actual Study Start Date: November 2011
• Actual Primary Completion Date: July 2013
• Actual Study Completion Date: October 2013

Arms and Interventions

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 Name: haloperidol

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Sponsors and Collaborators

Michelle Weckmann

American Cancer Society, Inc.

Investigators

• Principal Investigator: Michelle Weckmann, MD; University of Iowa

More Information

• Responsible Party: Michelle Weckmann, Clinical Assistant Professor, University of Iowa
• ClinicalTrials.gov Identifier: NCT03489551
• Other Study ID Numbers: 201107736
• First Posted: April 5, 2018
• Results First Posted: May 22, 2018
• Last Update Posted: May 22, 2018
• Last Verified: April 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Haloperidol; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Antipsychotic Agents; Tranquilizing Agents; Central Nervous System Depressants; Psychotropic Drugs; Dopamine Antagonists; Dopamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Dyskinesia Agents