Clinical Trial: Nexium Study To Suppress Nausea During Chemotherapy
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Evaluation of the Efficacy of Esomeprazole in Suppressing Nausea and Vomiting in Patients Undergoing Chemotherapy for Breast Cancer
Brief Summary: 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.
Detailed Summary:
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Breast Cancer
The American Cancer Society estimates that there will be approximately 215,990 new cases of breast cancer diagnosed in women during 2004 in the United States. Breast cancer is the most common malignancy in women in the United States and the second leading cause of cancer death in women.
Treatment options for breast cancer have evolved from extensive surgical approaches to breast-conserving techniques and the use of adjuvant and neo-adjuvant chemotherapy, radiation, and endocrine therapy to reduce the risk of recurrence.
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Chemotherapy in Breast Cancer
The use of adjuvant chemotherapy is a well established and routine part of care for breast cancer. Chemotherapy can reduce a woman's risk of recurrence by 25-30%. The amount of risk reduction depends on the patient's age, nodal status, and hormone receptor status.
Anthracycline-based chemotherapy is standard in the treatment of breast cancer with doxorubicin being the most frequently used agent in this group. Currently the most commonly used chemotherapy regimens for breast cancer include: * doxorubicin/cyclophosphamide (AC) * fluorouracil/doxorubicin/cyclophosphamide (FAC) * cyclophosphamide/methotrexate/fluorouracil (CMF) * docetaxel/doxorubicin/cyclophosphamide (TAC) * fluorouracil/epirubicin/cyclophosphamide (FEC) * single agent taxanes (paclitaxel and docetaxel) Except for the taxanes, these agents are known to cause significant nausea and vomiting after administration.
Cancer drugs differ both quantitatively and qualitatively in their emetogenic po
Sponsor: Baylor Breast Care Center
Current Primary Outcome: 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.
Original Primary Outcome: The Purpose of This Study is to Determine Whether Esomeprazole Significantly Decreases the Incidence, Severity and Duration of Nausea/Vomiting/Retching in Breast Cancer Patients Who Are Receiving Anthracycline-based Chemotherapy.
Current Secondary Outcome: 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 ]
Original Secondary Outcome: 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.
Information By: Baylor Breast Care Center
Dates:
Date Received: September 13, 2005
Date Started: August 2005
Date Completion:
Last Updated: April 27, 2012
Last Verified: April 2012
