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

Primary Purpose

Stem Cell Transplant Complications, Delirium

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Haldol

About this trial

This is an interventional supportive care trial for Stem Cell Transplant Complications

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oral Haldol in patients undergoing HSCT

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03489551

First Posted

March 29, 2018

Last Updated

April 22, 2018

Sponsor

Michelle Weckmann

Collaborators

American Cancer Society, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03489551

Brief Title

Feasibility of Prophylactic Haldol to Prevent Delirium in Cancer Patients

Acronym

PHDC

Official Title

Feasibility of Prophylactic Haldol to Prevent Delirium in Cancer Patients

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

November 2011 (Actual)

Primary Completion Date

July 2013 (Actual)

Study Completion Date

October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Michelle Weckmann

Collaborators

American Cancer Society, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stem Cell Transplant Complications, Delirium

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oral Haldol in patients undergoing HSCT

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Haldol

Other Intervention Name(s)

haloperidol

Primary Outcome Measure Information:

Title

Side Effects and Tolerability of Haldol in Patients With Undergoing Hematopoietic Stem Cell Transplant

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michelle Weckmann, MD

Organizational Affiliation

University of Iowa

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Feasibility of Prophylactic Haldol to Prevent Delirium in Cancer Patients

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