Nexium Study To Suppress Nausea During Chemotherapy - Full Text View

Sponsor:	Baylor Breast Care Center
Collaborator:	AstraZeneca
Information provided by (Responsible Party):	Mothaffar Rimawi, Baylor Breast Care Center
ClinicalTrials.gov Identifier:	NCT00206440

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Nausea and Vomiting

Drug Information available for: Omeprazole Omeprazole magnesium Esomeprazole Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

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

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received:	September 13, 2005
Results First Received:	February 1, 2012
Last Updated:	April 27, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Baylor Breast Care Center:

chemotherapy
nausea
vomiting
breast cancer

Additional relevant MeSH terms:

Breast Neoplasms
Nausea
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Signs and Symptoms, Digestive
Signs and Symptoms

Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 24, 2012