A Pilot Study of Aprepitant vs. Placebo Combined With Standard Antiemetics for the Control of Nausea and Vomiting During Hematopoietic Cell Transplatation(HCT)
- Compare the efficacy of standard antiemetic therapy comprising ondansetron and
dexamethasone combined with either aprepitant or placebo in controlling nausea and
vomiting, as determined by the number of retch/emesis-free days, in patients undergoing
hematopoietic stem cell transplantation.
- Determine the safety of aprepitant in these patients.
- Compare nausea, appetite, taste changes, nutritional intake, and mucositis in patients
treated with these regimens.
- Determine the pharmacokinetics of cyclophosphamide, carboxyethylphosphoramide mustard,
hydroxycyclophylamide, and aprepitant in these patients.
OUTLINE: This is a randomized, placebo-controlled, single-blind, pilot study. Patients are
randomized to 1 of 2 treatment arms.
- Arm I: Beginning on the first day of conditioning chemotherapy, patients receive oral
aprepitant once daily and standard antiemetic therapy comprising oral or IV ondansetron
and oral dexamethasone.
- Arm II: Patients receive oral placebo once daily and standard antiemetic therapy as in
In both arms, treatment continues until day 4 after stem cell transplant in the absence of
After completion of study therapy, patients are followed until day 18.
PROJECTED ACCRUAL: A total of 40 patients (20 per treatment arm) will be accrued for this
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Number of Emesis Free Participants During the Study Period.
To compare the efficacy of aprepitant plus standard therapy to placebo plus standard therapy in control of nausea and vomiting during conditioning therapy for autologous or allogeneic hematopoietic stem cell transplantation (HSCT) as defined by the number of retch/emesis free days during the study period
Up to three weeks
Joseph Bubalo, PharmD
OHSU Knight Cancer Institute
United States: Federal Government
|OHSU Knight Cancer Institute||Portland, Oregon 97239|