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A real-world study for the use of thiopentyl injection in the prevention of chemotherapy-related neutrophil deficiency

A real-world study for the use of thiopentyl injection in the prevention of chemotherapy-related neutrophil deficiency

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800019490
Enrollment
Unknown
Registered
2018-11-14
Start date
2018-11-30
Completion date
Unknown
Last updated
2018-11-19

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

Conditions

Prevention of chemotherapy related neutrophilic granulocytic deficiency

Interventions

Case series:Mecapegfilgrastim Injection

Sponsors

Baotou Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients with breast cancer confirmed by histopathology should be treated with neoadjuvant chemotherapy or adjuvant chemotherapy, which is suitable for the chemotherapy regimen prescribed in this study; 2. Patients satisfy one of the following conditions: patients with grade III/IV neutropenia in previous chemotherapy cycles have planned to use the same regimen in subsequent cycles; patients with FN risk > 20% have chosen the regimen, and patients with FN risk of 10-20% have more than one risk factor; 3. hematopoietic function is normal, no bleeding tendency (INR<1.5); 4. laboratory tests should be consistent with: 1) blood routine examination: Hb=90g/L; WBC=4 x 10^9/L; ANC=2 x 10^9/L; PLT=100 x 10^9/L. 2) liver function and biochemistry examination: ALT and AST=1.5 x ULN; TBIL=1.5 x ULN; serum creatinine=1.5 x ULN. 5. judged by the researchers, they can observe the test plan; 6. the volunteers voluntarily joined the study, signed informed consent, and had good compliance and follow-up.

Exclusion criteria

Exclusion criteria: 1. pregnant or lactating women; 2. there are other hematological diseases that affect hematopoietic function of bone marrow; 3. allergy to research agents or other G-CSF products and biological agents expressed by E. coli; 4. according to the researchers, there are serious diseases that endanger the safety of patients or affect the completion of research; The researchers judged that other circumstances were not suitable for inclusion in this study.

Design outcomes

Primary

MeasureTime frame
Reduce the incidence of the first cycle of 3 and 4 degrees ANC by sulphur group.;

Secondary

MeasureTime frame
the incidence of 3 and 4 degree ANC reduction started with the second cycle of sulphur;Incidence of febrile neutropenia (FN) during the use of sulphfefevertin;Proportion of antibiotics used during treatment;The incidence of adverse reactions during the period of chemotherapy with sulphur and FGM;

Countries

China

Contacts

Public ContactZhu Jingjun

Baotou Cancer Hospital

592676401@qq.com+86 13848020714

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026