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

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 Overview

• Status: Completed
• Conditions: Non-myeloid Malignant Tumors

• Study Type: Observational
• Enrollment (Actual): 3000

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Breast cancer, lung cancer, colorectal cancer, gynecological cancers, esophageal cancer, head and neck cancers, and other non-myeloid malignant tumors.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Retrospective study group
Prospective study group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness: Incidence of FN and Grade 3/4 Neutropenia	Incidence of FN (febrile neutropenia) per chemotherapy cycle；; Incidence of grade 3/4 neutropenia per chemotherapy cycle	Observe for 14 days after each chemotherapy, at least two chemotherapy cycles and at most eight chemotherapy cycles (14 or 21 days per cycle).

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2024
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: January 4, 2026
• First Submitted That Met QC Criteria: February 6, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 6, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: TJ-IRB202402079

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No