Evaluation of the Efficacy of Esomeprazole in Suppressing Nausea and Vomiting in Patients Undergoing Chemotherapy for Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Number of Times a Subject Felt Sick to Her Stomach and Number of Times a Subject Required Rescue Medication
研究概览
简要总结
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.
详细描述
- 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. 2. 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Esomeprazole
Patients receiving chemotherapy (anthracycline-based) will be randomized to esomeprazole for Cycle 1 Days 1-5 and Cycle 2 Days 1-5
干预措施: esomeprazole (Drug)
Sugar pill
Subjects will be given placebo Cycle 1 Days 1-5 and Cycle 2 Days 1-5.
干预措施: Placebo (Other)
结局指标
主要结局
Number of Times a Subject Felt Sick to Her Stomach and Number of Times a Subject Required Rescue Medication
时间窗: 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.
次要结局
未报告次要终点
研究者
Mothaffar Rimawi
Medical Director
Baylor Breast Care Center