Feasibility of Prophylactic Haldol to Prevent Delirium in Cancer Patients

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Michelle Weckmann
• Collaborator: American Cancer Society, Inc.
• Treatments: Haloperidol; Haloperidol decanoate

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.