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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

Tracking Information
First Submitted Date  ICMJE March 29, 2018
First Posted Date  ICMJE April 5, 2018
Results First Submitted Date  ICMJE April 22, 2018
Results First Posted Date  ICMJE May 22, 2018
Last Update Posted Date May 22, 2018
Actual Study Start Date  ICMJE November 2011
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03489551 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility of Prophylactic Haldol to Prevent Delirium in Cancer Patients
Official Title  ICMJE Feasibility of Prophylactic Haldol to Prevent Delirium in Cancer Patients
Brief 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.

Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Stem Cell Transplant Complications
  • Delirium
Intervention  ICMJE Drug: Haldol
Other Name: haloperidol
Study Arms  ICMJE 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.
Intervention: Drug: Haldol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 29, 2018)
17
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03489551
Other Study ID Numbers  ICMJE 201107736
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Michelle Weckmann, University of Iowa
Study Sponsor  ICMJE Michelle Weckmann
Collaborators  ICMJE American Cancer Society, Inc.
Investigators  ICMJE
Principal Investigator: Michelle Weckmann, MD University of Iowa
PRS Account University of Iowa
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP