Nexium Study To Suppress Nausea During Chemotherapy
Condition: Nausea
MeSH terms: Nausea
Intervention: esomeprazole; Placebo
Intervention description: nexium; Placebo 1 pill daily Cycle 1 Days 1-5 and Cycle 2 Days 1-5
Intervention MeSH terms: Esomeprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 43.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: chemotherapy; nausea; vomiting; breast cancer

Summary:

      This study will look at a drug called esomeprazole, the newest PPI, as a way to further
      reduce the amount of nausea and vomiting seen in breast cancer patients receiving adriamycin
      or epirubicin chemotherapy. Esomeprazole may help protect the gut lining from the stomach
      acid and thus lessen the nausea and vomiting. If patients have less stomach sickness, they
      may be able to enjoy their daily routines much more while they are getting chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

        For inclusion, participants must:

          -  be female, age 18 years or older

          -  sign an informed consent

          -  have Stage I, II, or III breast cancer

          -  be receiving at least four cycles of anthracycline-based chemotherapy which may
             include: doxorubicin/cyclophosphamide AC),5-fluorouracil/doxorubicin/cyclophosphamide
             (FAC), fluoruracil/epirubicin/cyclophosphamide (FEC) or dose dense chemotherapy
             regimen (AC every two weeks) as their agents for neoadjuvant or adjuvant chemotherapy

          -  patient must receive a serotonin receptor antagonist and a steroid for premedication

          -  have a negative serum pregnancy test within 7 days prior to starting study if
             pre-menopausal

          -  have adequate renal function, defined by a serum creatinine within 1.5 times the upper
             limit of normal

          -  have adequate liver function, defined by a total bilirubin, SGOT, alkaline phosphatase
             and albumin within 1.5 times the upper limits of normal

          -  have adequate bone marrow function, defined as a WBC >4.0, platelet count >100K, and
             HCT >30

          -  have no prior or current malignancies for which chemotherapy was utilized

          -  have a performance status of at least 2 according to the Eastern Cooperative Oncology
             Group World Health Organization or a Karnofsky score of 50% or greater.

        Exclusion Criteria:

          -  pregnancy or unwillingness to use a reliable contraceptive method in women of
             child-bearing potential

          -  severe or underlying chronic illness or disease

          -  renal insufficiency or liver abnormalities

          -  chronic use of steroids

          -  uncontrolled GERD

          -  current use of proton pump inhibitors

          -  history of Barrett's esophagus

          -  history of erosive gastritis

          -  intolerance to serotonin receptor antagonists

          -  current use of aprepitant or palonosetron as antiemetics

          -  concomitant use of H2-receptor antagonists (ranitidine, cimetidine, famotidine or
             nizatidine) or metaclopramide