Feasibility of Prophylactic Haldol to Prevent Delirium in Cancer Patients

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2013

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.

Interventions

  • Drug: Haldol

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Michelle Weckmann
  • Collaborator
    • American Cancer Society, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Michelle Weckmann, Clinical Assistant Professor – University of Iowa
  • Overall Official(s)
    • Michelle Weckmann, MD, Principal Investigator, University of Iowa

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.