Aprepitant in Preventing Nausea and Vomiting in Patients Who Are Undergoing a Stem Cell Transplant
A Pilot Study of Aprepitant vs. Placebo Combined With Standard Antiemetics for the Control of Nausea and Vomiting During Hematopoietic Cell Transplatation(HCT)
4 other identifiers
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable cancer
Started May 2004
Longer than P75 for not_applicable cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
November 3, 2005
CompletedFirst Posted
Study publicly available on registry
November 4, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedResults Posted
Study results publicly available
December 21, 2011
CompletedMay 9, 2017
May 1, 2017
4.7 years
November 3, 2005
November 21, 2011
May 7, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
Safety in Transplant Population
Up to three weeks
Effects on Nausea, Appetite and Taste Changes
Up to three weeks
Pharmacokinetic Interaction
Up to three weeks
Study Arms (2)
Aprepitant
ACTIVE COMPARATORsugar pill
PLACEBO COMPARATORLoading 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
Interventions
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
For Cyclophosphamide Total Body Irradiation(CyTBI) patients: Dexamethasone study drug 1 capsule PO daily, 1 hour prior to chemotherapy with aprepitant on total body irradiation(TBI) and cyclophosphamide chemotherapy days; For Busulfan Cyclophosphamide(BuCy) patients: Dexamethasone 1 capsule orally once daily, discontinue after last dose of chemotherapy.
For CyTBI patients: Ondansetron 8 mg orally evert 12 hours, begin 1 hour prior to first TBI dose and discontinue after last dose; then Ondansetron 8 mg IV every 12 hours X 4 doses, begin 30 minutes prior to first cyclophosphamide chemotherapy; For BuCy patients: Ondansetron 8 mg orally every 6 hours, begin 1 hour prior to first busulfan dose and discontinue after last busulfan dose is given. then: Ondansetron 8 mg IV Q 12 hours X 4 doses, begin 30 minutes prior to first cyclophosphamide chemotherapy
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
Eligibility Criteria
You may qualify if:
- years of age or greater
- must be scheduled for an autologous or allogeneic bone marrow or peripheral stem cell transplant
- Eastern Cooperative Oncology Group(ECOG) performance status \< or = 2
- patients must have signed informed consent
- must be able to swallow tablets and capsules
- must be receiving a cyclophosphamide containing regimen.
You may not qualify if:
- patient has known sensitivity to aprepitant, ondansetron, or dexamethasone
- patient has received another investigational drug in the past 30 days
- patient has had emesis or requires antiemetic agents in the 48 hours prior to beginning conditioning therapy
- patient has taken neurokinin-1 antagonists for 14 days prior to enrollment
- patient is pregnant, has a positive serum human chorionic gonadotropin(hCg) or is lactating
- patient has serum creatinine level \> or = 2\*ULN
- patient has severe hepatic insufficiency (Child-Pugh score \>9)
- patient drinks \> 5 drinks/day for the last year
- patient with concurrent illness requiring systemic corticosteroid use other than planned dexamethasone during conditioning therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
OHSU Knight Cancer Institute
Portland, Oregon, 97239-3098, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Joseph Bubalo, PharmD
- Organization
- Oregon Health & Science University, Knight Cancer Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph Bubalo, PharmD
OHSU Knight Cancer Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PharmD
Study Record Dates
First Submitted
November 3, 2005
First Posted
November 4, 2005
Study Start
May 1, 2004
Primary Completion
January 1, 2009
Study Completion
January 1, 2009
Last Updated
May 9, 2017
Results First Posted
December 21, 2011
Record last verified: 2017-05