---
title: Feasibility of Prophylactic Haldol to Prevent Delirium in Cancer Patients
nct_id: NCT03489551
overall_status: COMPLETED
phase: PHASE4
sponsor: Michelle Weckmann
study_type: INTERVENTIONAL
primary_condition: Stem Cell Transplant Complications
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03489551.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03489551"
ct_last_update_post_date: 2018-05-22
last_seen_at: "2026-05-12T07:09:19.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Feasibility of Prophylactic Haldol to Prevent Delirium in Cancer Patients

**NCT ID:** [NCT03489551](https://clinicaltrials.gov/study/NCT03489551)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 17
- **Lead Sponsor:** Michelle Weckmann
- **Collaborators:** American Cancer Society, Inc.
- **Conditions:** Stem Cell Transplant Complications, Delirium
- **Start Date:** 2011-11
- **Completion Date:** 2013-10
- **CT.gov Last Update:** 2018-05-22

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 80 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **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.

## Interventions

- **Haldol** (DRUG)

## Primary Outcomes

- **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

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03489551.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03489551*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*