Feasibility of Prophylactic Haldol to Prevent Delirium in Cancer Patients (PHDC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03489551|
Recruitment Status : Completed
First Posted : April 5, 2018
Results First Posted : May 22, 2018
Last Update Posted : May 22, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Stem Cell Transplant Complications Delirium||Drug: Haldol||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Feasibility of Prophylactic Haldol to Prevent Delirium in Cancer Patients|
|Actual Study Start Date :||November 2011|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||October 2013|
Experimental: Oral Haldol in patients undergoing HSCT
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.
Other Name: haloperidol
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03489551
|Principal Investigator:||Michelle Weckmann, MD||University of Iowa|