Nausea Clinical Trial
Official title:
Prevention of Nausea and Vomitting Associated With Stem Cell Transplant: Results of a Prospective, Randomized Trial of Aprepitant Used With Highly Emetogenic Preparative Regimens
The purpose of this study is to compare two different treatment protocols for treating nausea
and vomiting in patients who have undergone bone marrow transplant. Patients will be assigned
to one of two treatment groups.
The first group will recieve ondansetron (Zofran) tablets combined with a medicine called
dexamethasone given IV. Both of these drugs are commercially available.
Patients in the second treatment consists of the first two drugs, plus a newly approved drug
known as aprepitant (MK-869, Emend). This combination will be the treatment being tested. The
combination is approved by the FDA for chemotherapy regimens known to cause a lot of nausea
and vomiting. It significantly decreases the delayed (more than 24 hours after therapy)
nausea and vomiting seen with these regimens.
This will be a single center, comparative, randomized, double-blind, phase III trial designed
to evaluate the efficacy of the NK-1 antagonist, aprepitant (MK-869), in combination with
ondansetron and dexamethasone in the prevention of acute and delayed nausea and vomiting
compared to ondansetron and dexamethasone in patients receiving highly emetogenic preparative
regimens prior to autologous or allogeneic (related and unrelated) stem cell transplantation.
Patients will be randomized to one of two treatments: dexamethasone 10 mg IV once daily and
ondansetron 8 mg orally every 8 hours on each day of the preparative regimen plus one
additional day vs. 7.5 mg IV once daily and ondansetron 8 mg orally every 8 hours on each day
of the preparative regimen plus one additional day combined with aprepitant, 125 mg orally on
the first day of their preparative regimen followed by 80 mg daily on each remaining day of
the preparative regimen plus three additional days.
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