Nexium Study To Suppress Nausea During Chemotherapy (NEXIUM)
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ClinicalTrials.gov Identifier: NCT00206440 |
Recruitment Status :
Terminated
(Accrual was not optimized)
First Posted : September 21, 2005
Results First Posted : March 7, 2012
Last Update Posted : December 6, 2018
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Condition or disease | Intervention/treatment | Phase |
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Nausea | Drug: esomeprazole Other: Placebo | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 43 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Evaluation of the Efficacy of Esomeprazole in Suppressing Nausea and Vomiting in Patients Undergoing Chemotherapy for Breast Cancer |
Study Start Date : | August 2005 |
Actual Primary Completion Date : | February 2009 |
Actual Study Completion Date : | February 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Esomeprazole
Patients receiving chemotherapy (anthracycline-based) will be randomized to esomeprazole for Cycle 1 Days 1-5 and Cycle 2 Days 1-5
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Drug: esomeprazole
nexium
Other Name: nexium |
Placebo Comparator: Sugar pill
Subjects will be given placebo Cycle 1 Days 1-5 and Cycle 2 Days 1-5.
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Other: Placebo
Placebo 1 pill daily Cycle 1 Days 1-5 and Cycle 2 Days 1-5
Other Name: Sugar Pill |
- Number of Times a Subject Felt Sick to Her Stomach and Number of Times a Subject Required Rescue Medication [ Time Frame: 2-7 days following chemotheraphy ]Proportion of patients who exhibit no more than one emetic episode and who do not require rescue medication for nausea from 2-7 days following chemotherapy. Thus, we will look at esomeprazole when used to decrease the incidence,severity and duration of nausea/vomiting/retching in breast cancer patients who are receiving anthracycline-based chemotherapy.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00206440
United States, Texas | |
Baylor Breast Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Mothaffar Rimawi, MD | Baylor Breast Center |
Responsible Party: | Mothaffar Rimawi, Medical Director, Baylor Breast Care Center |
ClinicalTrials.gov Identifier: | NCT00206440 |
Other Study ID Numbers: |
H-16348 Nexium Study ( Other Identifier: Baylor College of Medicine ) |
First Posted: | September 21, 2005 Key Record Dates |
Results First Posted: | March 7, 2012 |
Last Update Posted: | December 6, 2018 |
Last Verified: | November 2018 |
chemotherapy nausea vomiting breast cancer |
Nausea Signs and Symptoms, Digestive Esomeprazole Anti-Ulcer Agents |
Gastrointestinal Agents Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |