Stem Cell Transplant ComplicationsPhase 4PHDCNCT03489551
Feasibility of Prophylactic Haldol to Prevent Delirium in Cancer Patients
A Phase 4 study testing Haldol in people with Stem Cell Transplant Complications and Delirium, run by Michelle Weckmann.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stem Cell Transplant Complications, Delirium
- What is being tested?
- Haldol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- Nov 2011to Oct 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
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.
Read the 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.
- Conditions
- Stem Cell Transplant Complications, Delirium
- Being tested
- Haldol
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HaldolDrug
Also called haloperidol
| Study group | Role | What they receive |
|---|---|---|
| Oral Haldol in patients undergoing HSCT | Experimental | 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. Receives: Drug: Haldol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Side Effects and Tolerability of Haldol in Patients With Undergoing Hematopoietic Stem Cell Transplant
Categorize and quantify adverse events from start of drug (day 1) to end of study drug per (CTCAE) version 4.0
Measured: Daily, up to 14 days following transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study startNov 2011
- Primary completionJul 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stem Cell Transplant ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michelle Weckmann
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor-investigator, Michelle Weckmann, University of Iowa
- Investigators
- Michelle Weckmann, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03489551
- Sponsor's protocol ID
- 201107736
- Acronym
- PHDC
- Status last verified
- Apr 2018
- First submitted
- 29 Mar 2018
- Last updated
- 22 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Prophylactic Haldol to Prevent Delirium in Cancer Patients
- ClinicalTrials.gov ID
- NCT03489551
- Acronym / sponsor ID
- PHDC / 201107736
- Conditions
- Stem Cell Transplant Complications, Delirium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Michelle WeckmannUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- Nov 2011 (actual)
- Primary completion
- Jul 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 5 Apr 2018 (actual)
- Results
- Posted 22 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral Haldol in patients undergoing HSCT | Experimental | Drug: HaldolPrior 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HaldolAlso: haloperidol | Drug | Oral Haldol in patients undergoing HSCT |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Weckmann, MD principal investigator
University of Iowa
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Haldol in people with Stem Cell Transplant Complications and Delirium, run by Michelle Weckmann.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Side Effects and Tolerability of Haldol in Patients With Undergoing Hematopoietic Stem Cell Transplant (time frame: Daily, up to 14 days following transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2018.