Phase 4
Completed N=17
Feasibility of Prophylactic Haldol to Prevent Delirium in Cancer Patients
Stem Cell Transplant Complications · Delirium
Source: ClinicalTrials.gov NCT03489551 ↗
Enrolled (actual)
17
Serious AEs
0.0%
Results posted
May 2018
Primary outcomePrimary: Side Effects and Tolerability of Haldol in Patients With Undergoing Hematopoietic Stem Cell Transplant — 1 Adverse Event
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Side Effects and Tolerability of Haldol in Patients With Undergoing Hematopoietic Stem Cell Transplant |
1 | — |
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.
Data sourced from ClinicalTrials.gov (NCT03489551). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.