Comparison of the effects of Pegagen and G-csf in the treatment of cytopenia induced by breast cancer chemotherapy

Comparison of the effects of Pegagen and G-csf in the chemotherapy induced cytopennia in the breast cancer patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT2017020732444N1

Enrollment

Registered

2017-03-30

Start date

2015-09-28

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Breast cancer. Malignant neoplasm of breast

Interventions

Intervention 1: first group: single dose of 6 mgr Pegagen used after the completion of first course of chemotherapy and 300 ugr G-csf daily for 5 days used at the end of the second course. Interventi

Treatment - Drugs

first group: single dose of 6 mgr Pegagen used after the completion of first course of chemotherapy and 300 ugr G-csf daily for 5 days used at the end of the second course

second group: after completion of the first course of chemotherapy 300 ugr G-csf daily for 5 days used and at the end of the second course single dose of 6 mgr Pegagen used

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria: age >18 years old; absolute neutrophil count =1.5 × 109/l; platelet count =100 × 109/l; serum creatinine <1.5 × upper limit of normal. Exclusion criteria: hypersinsitivity reaction; unwillingness of patients to continue; change of chemotherapy regimen.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Neutrophil count. Timepoint: before chemothrapy and 1 weeks and 2 weeks later. Method of measurement: laboratory CBC.;Hb level. Timepoint: before chemothrapy and 1 weeks and 2 weeks later. Method of measurement: laboratory CBC.;Platelet count. Timepoint: before chemothrapy and 1 weeks and 2 weeks later. Method of measurement: laboratory CBC.;Drug reaction. Timepoint: before chemothrapy and 1 weeks and 2 weeks later. Method of measurement: questionnaire.;Wbc count. Timepoint: before chemothrapy and 1 weeks and 2 weeks later. Method of measurement: laboratory CBC.	—

Measure

Time frame

Neutrophil count. Timepoint: before chemothrapy and 1 weeks and 2 weeks later. Method of measurement: laboratory CBC.;Hb level. Timepoint: before chemothrapy and 1 weeks and 2 weeks later. Method of measurement: laboratory CBC.;Platelet count. Timepoint: before chemothrapy and 1 weeks and 2 weeks later. Method of measurement: laboratory CBC.;Drug reaction. Timepoint: before chemothrapy and 1 weeks and 2 weeks later. Method of measurement: questionnaire.;Wbc count. Timepoint: before chemothrapy and 1 weeks and 2 weeks later. Method of measurement: laboratory CBC.

—

Secondary

Measure	Time frame
Fever. Timepoint: before chemotherapy and 1 week and 2 weeks later. Method of measurement: questionnaire.;Abdominal pain. Timepoint: before chemotherapy and 1 week and 2 weeks later. Method of measurement: questionnaire.;Dyspnea. Timepoint: before chemotherapy and 1 week and 2 weeks later. Method of measurement: questionnaire.;Bone pain. Timepoint: before chemotherapy and 1 week and 2 weeks later. Method of measurement: questionnaire.;Hypersensitivity reactions. Timepoint: before chemotherapy and 1 week and 2 weeks later. Method of measurement: questionnaire.;Postpone chemotherapy. Timepoint: 2 weeks after chemotherapy. Method of measurement: questionnaire.	—

Measure

Time frame

Fever. Timepoint: before chemotherapy and 1 week and 2 weeks later. Method of measurement: questionnaire.;Abdominal pain. Timepoint: before chemotherapy and 1 week and 2 weeks later. Method of measurement: questionnaire.;Dyspnea. Timepoint: before chemotherapy and 1 week and 2 weeks later. Method of measurement: questionnaire.;Bone pain. Timepoint: before chemotherapy and 1 week and 2 weeks later. Method of measurement: questionnaire.;Hypersensitivity reactions. Timepoint: before chemotherapy and 1 week and 2 weeks later. Method of measurement: questionnaire.;Postpone chemotherapy. Timepoint: 2 weeks after chemotherapy. Method of measurement: questionnaire.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMehrzad Salmasi

Isfahan University of Medical Sciences

mehrzad_salmasi@yahoo.com+98 31 3263 0366

Outcome results

None listed

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