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A New Exploration of the Time Node of Polyethylene Glycolized Recombinant Human Granulocyte Colony-stimulating Factor

A New Exploration of the Time-Point of Use of Polyethylene Glycol-conjugated Recombinant Human Granulocyte Colony-Stimulating Factor after Chemotherapy for Breast Cancer, a Single-Center, Cohort, Interventional Phase IV Clinical Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100051414
Enrollment
Unknown
Registered
2021-09-23
Start date
2021-10-01
Completion date
Unknown
Last updated
2022-06-20

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

Conditions

breast cancer

Interventions

Group 1:PEG-rhG-CSF was injected 4 hours after chemotherapy
Group 2:PEG-rhG-CSF was injected 48 hours after chemotherapy

Sponsors

The Seventh Affiliated Hospital, Sun Yat-sen University (Shenzhen)
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18 to 65 years; 2.Breast cancer diagnosed by pathological histology or cytology; 3.Determine the patient's chemotherapy regimen and dose according to the latest CSCO guidelines for breast cancer treatment; 4.Patients who plan to complete their chemotherapy program at the same center; 5.ANC >= 1.5*10^9/L before chemotherapy; Platelets >= 80*10^9/L; Hemoglobin >= 100g/L; No significant abnormalities in liver and kidney function; 6.Understand the content of the study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Have an infection that is difficult to control or have received antibiotics within 72h prior to chemotherapy; 2.Patients with abnormal bone marrow hyperplasia and other abnormal hematopoietic functions; 3.Received a bone marrow or hematopoietic stem cell transplant within the previous 3 months; 4.During pregnancy or lactation; 5.There are obvious signs of blood system diseases and serious complications.

Design outcomes

Primary

MeasureTime frame
The incidence of neutropenic fever;

Secondary

MeasureTime frame
Incidence of chemotherapeutic dose adjustment and chemotherapy delay due to neutropenia during each cycle of chemotherapy;Salvage RHG-CSF utilization rate;Antibiotic utilization rate;The cost of each cycle of chemotherapy;

Countries

China

Contacts

Public ContactLei Kefeng

The Seventh Affiliated Hospital, Sun Yat-sen University (Shenzhen)

leikefeng@sysush.com+86 18529598502

Outcome results

None listed

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