Neutropenia. Neutropenia
Conditions
Interventions
Intervention 1: Invention group : Administration of Filgrastim ZistDaru at a dose of 300 mcg, 24-48 hours after the first cycle of chemotherapy until ANC more than 5*10 9 and maximum for 10 days (each
Sponsors
Zistdaru Danesh Co. ®
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Female gender age between 18 and 70 years with weight range of 40-100 kg . Agree to participate in the study and sign an informed consent form. Recognized with breast cancer treated with doxorubicin hydrochloride (Adriamycin) and cyclophosphamide (AC) regimen Eastern Cooperative Oncology Group (ECOG) one and zero Candidate for preventive use for neutropenia (according to American society of clinical oncology (ASCO) guideline recommendation for prophylaxis of filgrastim in patients receiving chemotherapy regimens with more than 20% chance of developing neutropenia fever) Use at least one method of contraception from 4 weeks before the study until the end of the study Life expectancy more than 3 months Having the ability to receive treatment and follow-up Karnofsky performance status = 70% for patients = 70 years of age and = 90% for patients > 70 years of age; adequate hematologic function (absolute neutrophil count [ANC] =3000 cells/µL, platelet count >100,000/µL, hemoglobin [Hb] = 8 g/dL); adequate hepatic function (bilirubin = 1.5 × upper limit of normal [ULN], aspartate aminotransferase and alanine aminotransferase = 2.5 × ULN, alkaline phosphatase = 5 × ULN); creatinine = 2.0 × ULN; and normal cardiac function as determined by MUGA (multiple-gated acquisition) scan or echocardiography.
Exclusion criteria
Exclusion criteria: Existence of any serious systemic disorders associated with granulocyte-colony stimulating factor (GCSF) incompatibility administration Uncontrolled blood pressure history or other systemic disease Heart failure regarding AC chemotherapy intolerability Known severe coagulation disorder (hemophilia A or B) Participate in another clinical trial up to 30 days prior to drug administration Any chemotherapy in the last five years Receive doxorubicin> 600 mg/m2 or Epirubicin > 240 mg/m2 History of hypersensitivity to natural GCSF or recombinant human albumin Systemic or local infection or receive any antibiotic up to 10 days prior to study recruitment Receive concomitant radiotherapy or 4 weeks before enrollment Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of Days that severe neutropenia occurs during the first chemotherapy cycle according to absolute neutrophil count < 500 per microliter of blood. Timepoint: The first chemotherapy cycle. Method of measurement: Absolute number of blood neutrophils in terms of number per microliter of blood. | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurance of febrile neutropenia. Timepoint: The start of medication in both groups until the last visit. Method of measurement: Fever over 38.5 centigrade degree for at least 1 hour and neutropenia less than 500 per microlitr blood coincidence.;Incidence of neutropenia defined as absolute neutrophil count < 0.5 x 10e9/L not associated with fever. Timepoint: The start of medication in both groups until the last visit. Method of measurement: Absolute neutrophil count per microliter of blood and fever measurement with thermometer (temperature more than 38 degree of centigrade) .;Determine the exact count of neutrophils. Timepoint: The start of medication administration in both groups until the last visit. Method of measurement: Absolute neutrophil count per each microliter of blood.;Incidence of infections. Timepoint: The start of medication in both groups until the last visit. Method of measurement: According to blood, respiratory secretion or urine culture.;Incidence of need for IV anti-infectives. Timepoint: The start of medication in both groups until the last visit. Method of measurement: According to the results of the culture or clinical symptoms.;As a result of neutropenia Incidence of hospitalization. Timepoint: The start of medication in both groups until the last visit. Method of measurement: Patient history taking.;As a result of neutropenia ,Duration of hospitalization. Timepoint: The start of medication in both groups until the last visit. Method of measurement: Patient visit.;Ability to maintain planned chemotherapy dose on time for cycles 2 to 6. Timepoint: every chemotherapy cycle. Method of measurement: Patient visit.;Cumulative r-G-CSF dose. Timepoint: The start of medication in both groups until the last visit. Method of measurement: The number of filgrastim during the study period. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMaryam Azimi
Pharmed Pajoohan Viera
Outcome results
None listed