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

Michelle Weckmann

Status and phase: Completed; Phase 4

Conditions: Delirium; Stem Cell Transplant Complications

Treatments: Drug: Haldol

Study type: Interventional

Funder types: Other

Identifiers

NCT03489551

201107736

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Oral Haldol in patients undergoing HSCT

Experimental group

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.

Treatment:

Drug: Haldol