Odansetron and Dexamethasone Alone vs. Odansetron, Dexamethason and Apreptant to Prevent Nausea
Condition: Nausea; Vomiting
MeSH terms: Nausea; Vomiting
Intervention: Standard PO (Zofran + Dexamethason); Aprepitant (MK-869) + Standard PO
Intervention description: Dexamethasone 10 mg (dose blinded) in 50 ml D5W IVPB over 15 minutes daily + ondansetron 8mg PO q 8 hours - repeated qd of the preparative regimen and for 1 day after completion. A placebo capsule will be given daily on each day of the preparative regimen plus 3 days after. Antiemetic therapy will start a minimum of 30 minutes prior to and continued for 24 hours after completion of the preparative regimen.; Dexamethasone 7.5 mg (dose blinded) in 50 ml D5W IVPB over 15 min daily + ondansetron 8mg PO q 8 hours - repeated QD of the preparative regimen and for 1 day after completion. Aprepitant 125mg PO [blinded] will be given a minimum of 30 minutes prior to the preparative regimen on day 1. MK-Aprepitant 80mg PO [blinded] will be given will be given approximately 24 hours later starting on day 2 then each day of the preparative regimen plus 3 days after. Antiemetic therapy will start a minimum of 30 minutes prior to and continued for 24 hours after completion of the preparative regimen.
Intervention MeSH terms: Ondansetron; Aprepitant
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 181.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bone Marrow Transplant; Nausea; Vomiting; NK-1 antagonist

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of cancer, admitted for myelosupppresive stem cell transplantation. Included
             preparative regimens include: TBI/VP16/CY, TBI/CY, BU/CY (PO & IV), and BCV

          -  Age 18 or older

          -  Alcohol intake <100 gm/d for the last year (< approximately 5 drinks per day)

          -  Renal function: estimated or measured CrCl 50 ml/min

          -  Liver function: T.Bili <1.5, AST < 2x ULN, unless due to disease

          -  Able to swallow tablets and capsules

        Exclusion Criteria:

          -  Age < 18

          -  High alcohol intake [> 100 gm/d in the last year]

          -  Allergy or intolerance to: ondansetron or dexamethasone

          -  Renal dysfunction [measured or estimated CrCl < 50 ml/min]

          -  Liver dysfunction [T.Bili > 1.5, AST > 2x ULN, unless due to disease]

          -  Inability to swallow tablets or capsules

          -  Concurrent condition requiring systemic steroid use

          -  Nonmyeloablative SCT, patients receiving the conditioning regimens not included [see
             inclusion criteria]

          -  History of anticipatory nausea and vomiting