Nexium Study To Suppress Nausea During Chemotherapy

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Nausea

In brief

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.

Key facts

Study ID

NCT00206440

Run by

Baylor Breast Care Center

People needed

43

Starts

2005-08-01

Expected to finish

2012-02-01

Last updated by the study team

2018-12-06

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Baylor Breast Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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