A Real-World Study on the Efficacy, Safety, and Quality of Life of Different Treatment Approaches for Post-Chemotherapy Neutropenia in Cancer Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07409415

Enrollment

3000

Registered

2026-02-13

Start date

2024-02-15

Completion date

2025-06-30

Last updated

2026-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-myeloid Malignant Tumors

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

14 Years to No maximum

Healthy volunteers

Inclusion criteria

1. 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. 2. Patients who have received at least two cycles of chemotherapy. 3. Patients with a white blood cell (WBC) count \> 3.0 × 10⁹/L or an absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L before chemotherapy. 4. Patients with osteosarcoma or lymphoid leukemia must be ≥ 14 years of age; patients with other cancer types must be ≥ 18 years of age. 5. Patients who voluntarily agree to participate in this study. 6. Patients who do not develop serious complications after chemotherapy.

Exclusion criteria

1. Patients with psychiatric disorders. 2. Patients with language or communication barriers. 3. Patients with severe dysfunction of the liver, kidneys, heart, or lungs. 4. Patients with severe bone marrow suppression. 5. Patients who have received systemic bone radiotherapy within 15 days. 6. Patients who have experienced a significant infection within the two weeks prior to study entry.

Design outcomes

Primary

Measure	Time frame	Description
Effectiveness: Incidence of FN and Grade 3/4 Neutropenia	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

Countries

China

Outcome results