A Real-World Study on the Efficacy, Safety, and Quality of Life of Different Treatment Approaches for Post-Chemotherapy Neutropenia in Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Effectiveness: Incidence of FN and Grade 3/4 Neutropenia
研究概览
简要总结
This is a multi-center, retrospective + prospective, real-world observational study. It aims to investigate, through a relatively large sample size, the effectiveness and safety of different treatment approaches for preventing and managing neutropenia in cancer patients after chemotherapy. Additionally, it seeks to observe the impact of different treatment management models on the quality of life of cancer patients undergoing chemotherapy, so as to provide real-world evidence for selecting different treatment strategies for cancer patients after chemotherapy in the future.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with non-myeloid malignant tumors (such as breast cancer, lung cancer, colorectal cancer, gynecological cancers, esophageal cancer, head and neck cancers) through imaging, histopathological examination, etc.
- •Patients who have received at least two cycles of chemotherapy.
- •Patients with a white blood cell (WBC) count > 3.0 × 10⁹/L or an absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L before chemotherapy.
- •Patients with osteosarcoma or lymphoid leukemia must be ≥ 14 years of age; patients with other cancer types must be ≥ 18 years of age.
- •Patients who voluntarily agree to participate in this study.
- •Patients who do not develop serious complications after chemotherapy.
排除标准
- •Patients with psychiatric disorders.
- •Patients with language or communication barriers.
- •Patients with severe dysfunction of the liver, kidneys, heart, or lungs.
- •Patients with severe bone marrow suppression.
- •Patients who have received systemic bone radiotherapy within 15 days.
- •Patients who have experienced a significant infection within the two weeks prior to study entry.
研究组 & 干预措施
Prospective study group
Retrospective study group
结局指标
主要结局
Effectiveness: Incidence of FN and Grade 3/4 Neutropenia
时间窗: Observe for 14 days after each chemotherapy, at least two chemotherapy cycles and at most eight chemotherapy cycles (14 or 21 days per cycle).
1. Incidence of FN (febrile neutropenia) per chemotherapy cycle； 2. Incidence of grade 3/4 neutropenia per chemotherapy cycle
次要结局
未报告次要终点
研究者
Xianglin Yuan
Professor, Head of the cancer center
Huazhong University of Science and Technology