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Nexium Study To Suppress Nausea During Chemotherapy (NEXIUM)

This study has been terminated.
(Accrual was not optimized)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00206440
First Posted: September 21, 2005
Last Update Posted: May 2, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Mothaffar Rimawi, Baylor Breast Care Center
  Purpose
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.

Condition Intervention Phase
Nausea Drug: esomeprazole Drug: Esomeprazole (aka Nexium) Other: Placebo Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mothaffar Rimawi, Baylor Breast Care Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Safety of Esomeprazole When Used to Decrease the Incidence,Severity and Duration of Nausea/Vomiting/Retching in Breast Cancer Patients Who Are Receiving Anthracycline-based Chemotherapy. [ Time Frame: 10 years ]
Enrollment: 43
Study Start Date: August 2005
Study Completion Date: February 2012
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Esomeprazole
Patients receiving chemotherapy (anthracycline-based) will be randomized to esomeprazole for Cycle 1 Days 1-5 and Cycle 2 Days 1-5
 Drug: esomeprazole
nexium
Other Name: nexium
Drug: Esomeprazole (aka Nexium)
Esomeprazole (20 mg daily ranitidine 300 mg daily) during Cycle 1 Days 1-5 and Cycle 2 Days 1-5
Other Name: Nexium
Placebo Comparator: Sugar pill
Subjects will be given placebo Cycle 1 Days 1-5 and Cycle 2 Days 1-5.
 Other: Placebo
Placebo 1 pill daily Cycle 1 Days 1-5 and Cycle 2 Days 1-5
Other Name: Sugar Pill

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Texas
Baylor Breast Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor Breast Care Center
AstraZeneca
Investigators
Principal Investigator: Mothaffar Rimawi, MD Baylor Breast Center
  More Information

Additional Information:
Web site  This link exits the ClinicalTrials.gov site

Responsible Party: Mothaffar Rimawi, Medical Director, Baylor Breast Care Center
ClinicalTrials.gov Identifier: NCT00206440     History of Changes
Other Study ID Numbers: H-16348
Nexium Study ( Other Identifier: Baylor College of Medicine )
First Submitted: September 13, 2005
First Posted: September 21, 2005
Results First Submitted: February 1, 2012
Results First Posted: March 7, 2012
Last Update Posted: May 2, 2012
Last Verified: April 2012

Keywords provided by Mothaffar Rimawi, Baylor Breast Care Center:
chemotherapy
nausea
vomiting
breast cancer

Additional relevant MeSH terms:
Nausea
Signs and Symptoms, Digestive
Signs and Symptoms
Esomeprazole
Anti-Ulcer Agents
 Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action