Delirium, Stem Cell Transplant Complications
Conditions
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.
Interventions
DRUGHaldol
Sponsors
American Cancer Society, Inc.
Michelle Weckmann
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Side Effects and Tolerability of Haldol in Patients With Undergoing Hematopoietic Stem Cell Transplant | 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 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Haldol | 15 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Oral Haldol in Patients Undergoing HSCT |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Age, Continuous | 59.3 years |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 1 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
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
Time frame: Daily, up to 14 days following transplant
Population: Participants completing treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oral Haldol in Patients Undergoing HSCT | Side Effects and Tolerability of Haldol in Patients With Undergoing Hematopoietic Stem Cell Transplant | 1 Adverse Event |