Biomarkers of Fatigue Related to Adjuvant Chemotherapy for Breast Cancer: Evaluation of Plasma and Lymphocyte Expression.
试验速览
- 阶段
- 不适用
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Potential biomarkers related to chemotherapy induced fatigue
研究概览
简要总结
Fatigue is common in cancer patients receiving adjuvant chemotherapy. To further understand the mechanism of fatigue and search for potential biomarkers, we will conduct a prospective study with breast cancer patients receiving adjuvant chemotherapy.
详细描述
Patients with breast cancer undergoing adjuvant systemic chemotherapy based on the use of anthracyclines will be screened before the start of chemotherapy.
Patients whose scores on the brief fatigue inventory (BFI) increase after having received the first cycle of chemotherapy will be considered as having manifested fatigue. The patients whose fatigue won't worse following the first cycle of chemotherapy will be used as controls. We will collect blood samples of both groups before and 21 days after the start of chemotherapy. We will analyze the following biomarkers: IL2, IL10, TNF and TGFB-1 measured by amplification reaction; FSH, LH, estradiol, DHEA, DHEAS and cortisol hormones measured by chemiluminescent enzyme immunometric assay
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Non metastatic breast cancer;
- •Patients undergoing adjuvant chemotherapy
排除标准
- •hypothyroidism;
- •Depression;
- •heart disease or decompensated hypertension
结局指标
主要结局
Potential biomarkers related to chemotherapy induced fatigue
时间窗: 21 days after the start of chemotherapy
This study examines potential biomarkers of fatigue induced by chemotherapy both in the plasma and mononuclear fraction of the peripheral blood of patients with breast cancer
次要结局
未报告次要终点
研究者
Felipe Melo Cruz
PhD
Faculdade de Medicina do ABC