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Completed

NCT Number: NCT03489551

Feasibility of Prophylactic Haldol to Prevent Delirium in Cancer Patients

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.

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Key information

Conditions

Stem Cell Transplant Complications Confusion Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Haldol

Drug

Other names: haloperidol

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Michelle Weckmann

Other

Collaborators

  • American Cancer Society, Inc.

Registry information

Acronym: PHDC

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 5, 2018
Registry last updated
May 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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