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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
Michelle Weckmann, University of Iowa

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

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




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



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03489551


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

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Responsible Party: Michelle Weckmann, Clinical Assistant Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT03489551     History of Changes
Other Study ID Numbers: 201107736
First Posted: April 5, 2018    Key Record Dates
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

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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:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Haloperidol
Haloperidol decanoate
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