Aprepitant in Preventing Nausea and Vomiting in Patients Who Are Undergoing a Stem Cell Transplant
- Conditions
- Cancer
- Interventions
- Registration Number
- NCT00248547
- Lead Sponsor
- OHSU Knight Cancer Institute
- Brief Summary
RATIONALE: Antiemetic drugs, such as aprepitant, ondansetron, and dexamethasone, may help lessen or prevent nausea and vomiting in patients undergoing a stem cell transplant.
PURPOSE: This randomized clinical trial is studying aprepitant, ondansetron, and dexamethasone to see how well they work compared to placebo, ondansetron, and dexamethasone in preventing nausea and vomiting in patients who are undergoing a stem cell transplant.
- Detailed Description
OBJECTIVES:
Primary
* 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.
Secondary
* 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 arm I.
In both arms, treatment continues until day 4 after stem cell transplant in the absence of unacceptable toxicity.
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 study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aprepitant ondansetron - sugar pill dexamethasone Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant sugar pill placebo Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant Aprepitant aprepitant - Aprepitant dexamethasone - sugar pill ondansetron Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
- Primary Outcome Measures
Name Time Method Number of Emesis Free Participants During the Study Period. Up to three weeks 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
- Secondary Outcome Measures
Name Time Method Safety in Transplant Population Up to three weeks To assess the safety of aprepitant in the bone marrow transplant population
Effects on Nausea, Appetite and Taste Changes Up to three weeks To assess the effects of aprepitant on nausea, appetite, and taste changes, (via visual analogue scale \[VAS\]), nutritional intake, and mucositis in the bone marrow transplant population.
Pharmacokinetic Interaction Up to three weeks To assess the potential for aprepitant and cyclophosphamide to interact pharmacokinetically in a significant manner to change blood levels of aprepitant, cyclophosphamide, hydroxycyclophosphamide or CEPM.
Trial Locations
- Locations (1)
OHSU Knight Cancer Institute
🇺🇸Portland, Oregon, United States