Nexium Study To Suppress Nausea During Chemotherapy (NEXIUM)

This study has been terminated.
(Accrual was not optimized)
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Mothaffar Rimawi, Baylor Breast Care Center
ClinicalTrials.gov Identifier:
NCT00206440
First received: September 13, 2005
Last updated: April 27, 2012
Last verified: April 2012
  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:


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

  Show Detailed Description

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 July 08, 2014