Feasibility of Prophylactic Haldol to Prevent Delirium in Cancer Patients

Delirium Clinical Trial

— PHDC  

Official title:

Feasibility of Prophylactic Haldol to Prevent Delirium in Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03489551
• Other study ID #: 201107736
• Status: Completed
• Phase: Phase 4
• Start date: November 2011
• Est. completion date: October 2013

Study information

• Verified date: April 2018
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: October 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Delirium
• Stem Cell Transplant Complications

Intervention

Drug:
• Haldol

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Michelle Weckmann	American Cancer Society, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Daily, up to 14 days following transplant