A Real-World Study on the Efficacy, Safety, and Quality of Life of Different Treatment Approaches for Post-Chemotherapy Neutropenia in Cancer Patients
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 3,000
- Locations
- 1
- Primary Endpoint
- Effectiveness: Incidence of FN and Grade 3/4 Neutropenia
Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 14 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Prospective study group
Retrospective study group
Outcomes
Primary Outcomes
Effectiveness: Incidence of FN and Grade 3/4 Neutropenia
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported
Investigators
Xianglin Yuan
Professor, Head of the cancer center
Huazhong University of Science and Technology