Trial Outcomes & Findings for Feasibility of Prophylactic Haldol to Prevent Delirium in Cancer Patients (NCT NCT03489551)

Results Overview

Categorize and quantify adverse events from start of drug (day 1) to end of study drug per (CTCAE) version 4.0

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

17 participants

Primary outcome timeframe

Daily, up to 14 days following transplant

Results posted on

2018-05-22

Participant milestones
Measure	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
Overall Study STARTED	17
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	2

Reasons for withdrawal
Measure	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
Overall Study Withdrawal by Subject	2

Feasibility of Prophylactic Haldol to Prevent Delirium in Cancer Patients

Baseline characteristics by cohort
Measure	Oral Haldol in Patients Undergoing HSCT n=15 Participants 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
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=99 Participants
Age, Categorical >=65 years	4 Participants n=99 Participants
Age, Continuous	59.3 years n=99 Participants
Sex: Female, Male Female	0 Participants n=99 Participants
Sex: Female, Male Male	15 Participants n=99 Participants
Region of Enrollment United States	15 participants n=99 Participants

Timeframe: Daily, up to 14 days following transplant

Population: Participants completing treatment

Categorize and quantify adverse events from start of drug (day 1) to end of study drug per (CTCAE) version 4.0

Outcome measures
Measure	Oral Haldol in Patients Undergoing HSCT n=15 Participants 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
Side Effects and Tolerability of Haldol in Patients With Undergoing Hematopoietic Stem Cell Transplant	1 Adverse Event

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Oral Haldol in Patients Undergoing HSCT n=15 participants at risk 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
General disorders Excessive sedation	6.7% 1/15 • Number of events 1

University of Iowa

Phone: 319-384-7538