Malignant neoplasm of breast. Malignant neoplasm of breast
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Newly diagnosed invasive breast cancer The Karnofsky Performance Scale Index equal to or more than 70% doxorubicin containing chemotherapy regimen Unilateral breast cancer Age between 18 to 70 years old
Exclusion criteria
Exclusion criteria: chronic liver failure chronic kidney failure chronic heart failure previous history of hematologic malignancies History of taking Psychiatric drugs Warfarin usage Bipolar mood disorder Evidence of metastasis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival. Timepoint: Every 3 months in the first year, every 4-6 months in the second year, every 6 months in third to fifth years and then annually. Method of measurement: visit.;Progression-free Survival. Timepoint: Every 3 months in the first year, every 4-6 months in the second year, every 6 months in third to fifth years and then annually. Method of measurement: Visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Anemia. Timepoint: Before each session of chemotherapy every two to three weeks. Method of measurement: laboratory assessment of Complete blood count.;Neutropenia. Timepoint: Before each session of chemotherapy every two to three weeks. Method of measurement: laboratory assessment of Complete blood count.;Thrombocytopenia. Timepoint: Before each session of chemotherapy every two to three weeks. Method of measurement: laboratory assessment of Complete blood count.;Alopecia. Timepoint: Before each session of chemotherapy every two to three weeks. Method of measurement: physical examination.;Nausea. Timepoint: Before each session of chemotherapy every two to three weeks. Method of measurement: history taking.;Vomiting. Timepoint: Before each session of chemotherapy every two to three weeks. Method of measurement: history taking.;Depression. Timepoint: In the first visit and then every four months. Method of measurement: Beck's Depression Inventory.;Anxiety. Timepoint: In the first visit and then every four months. Method of measurement: The Beck Anxiety Inventory. | — |
Countries
Iran (Islamic Republic of)
Contacts
Mashhad University of Medical Sciences