Feasibility of Prophylactic Haldol to Prevent Delirium in Cancer Patients

Michelle Weckmann17 enrolled

Overview

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.

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

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Stem Cell Transplant Complications Delirium

Interventions

HaldolDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: Daily, up to 14 days following transplant

Data from ClinicalTrials.gov

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