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

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ClinicalTrials.gov Identifier: NCT03489551
Recruitment Status : Completed
First Posted : April 5, 2018
Results First Posted : May 22, 2018
Last Update Posted : May 22, 2018
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
Michelle Weckmann, University of Iowa

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Stem Cell Transplant Complications
Delirium
Intervention Drug: Haldol
Enrollment 17
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Oral Haldol in Patients Undergoing HSCT
Hide Arm/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.

Haldol

Period Title: Overall Study
Started 17
Completed 15
Not Completed 2
Reason Not Completed
Withdrawal by Subject             2
Arm/Group Title Oral Haldol in Patients Undergoing HSCT
Hide Arm/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.

Haldol

Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
15 participants completed treatment
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
0
   0.0%
Between 18 and 65 years
11
  73.3%
>=65 years
4
  26.7%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 15 participants
59.3
(46.8 to 70.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
0
   0.0%
Male
15
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
1.Primary Outcome
Title Side Effects and Tolerability of Haldol in Patients With Undergoing Hematopoietic Stem Cell Transplant
Hide Description Categorize and quantify adverse events from start of drug (day 1) to end of study drug per (CTCAE) version 4.0
Time Frame Daily, up to 14 days following transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing treatment
Arm/Group Title Oral Haldol in Patients Undergoing HSCT
Hide Arm/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.

Haldol

Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: Adverse Event
1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Oral Haldol in Patients Undergoing HSCT
Hide Arm/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.

Haldol

All-Cause Mortality
Oral Haldol in Patients Undergoing HSCT
Affected / at Risk (%)
Total   0/15 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Oral Haldol in Patients Undergoing HSCT
Affected / at Risk (%) # Events
Total   0/15 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Oral Haldol in Patients Undergoing HSCT
Affected / at Risk (%) # Events
Total   1/15 (6.67%)    
General disorders   
Excessive sedation  1  1/15 (6.67%)  1
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Michelle Weckmann
Organization: University of Iowa
Phone: 319-384-7538
Responsible Party: Michelle Weckmann, University of Iowa
ClinicalTrials.gov Identifier: NCT03489551     History of Changes
Other Study ID Numbers: 201107736
First Submitted: March 29, 2018
First Posted: April 5, 2018
Results First Submitted: April 22, 2018
Results First Posted: May 22, 2018
Last Update Posted: May 22, 2018