Feasibility of Prophylactic Haldol to Prevent Delirium in Cancer Patients

NCT03489551 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 201107736
• Study Type: interventional
• Target: 17
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stem Cell Transplant Complications; Delirium

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Oral Haldol in patients undergoing HSCT

EXPERIMENTAL

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

Interventions

Haldol DRUG

Also known as: haloperidol

Oral Haldol in patients undergoing HSCT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Michelle Weckmann: lead
• American Cancer Society, Inc.: collaborator

MeSH Terms

Conditions

Delirium

Interventions

Haloperidol

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Butyrophenones; Ketones; Organic Chemicals

Results Point of Contact

• Title: Michelle Weckmann
• Organization: University of Iowa

michelle-weckmann@uiowa.edu

319-384-7538

Study Officials

• Michelle Weckmann, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: March 29, 2018
• First Posted: April 5, 2018
• Study Start: November 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: October 1, 2013
• Last Updated: May 22, 2018
• Results First Posted: May 22, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share