Breast cancer. Malignant neoplasm of breast
Conditions
Interventions
Intervention 1: Intervention group: 52 patients with breast cancer are randomly included in the intervention group. In addition to the neoadjuvant chemotherapy process, desloratadine 5mg (Neotadine® t
Sponsors
Gorgan University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Newly diagnosed breast cancer who are candidates for neoadjuvant chemotherapy (including patients with axillary lymphadenopathy, infraclavicular and supraclavicular lymphadenopathy/tumor size greater than 2 cm in triple-negative and Her2-enriched patients/skin involvement/inflammatory breast cancer and a large ratio of tumor to total breast). Not using antihistamines (anti-H1R and H2R receptors) No asthma Not having other cancers at the same time as breast cancer
Exclusion criteria
Exclusion criteria: Patients with immunological disorders Patients who are not eligible for chemotherapy Patients who have undergone breast surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate to treatment based on changes in tumor size and lymph node involvement. Timepoint: At the beginning of the study and 2 months after the start of the first course of chemotherapy. Method of measurement: RECIST criteria.;The serum level of tumor serological markers (CEA, CA15-3). Timepoint: At the beginning of the study and 2 months after the start of the first course of chemotherapy. Method of measurement: ELISA method. | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum level of Interleukin-6. Timepoint: At the beginning of the study and 2 months after the start of the first course of chemotherapy. Method of measurement: ELISA method.;Serum level of Tumor necrosis factor alpha. Timepoint: At the beginning of the study and 2 months after the start of the first course of chemotherapy. Method of measurement: ELISA method.;Serum level of Histamine. Timepoint: At the beginning of the study and 2 months after the start of the first course of chemotherapy. Method of measurement: ELISA method.;Expression level of Histamine receptor 1 (H1R), Toll-like receptor 4 (TLR4), and Nuclear factor kappa B (NF-kB). Timepoint: At the beginning of the study and 2 months after the start of the first course of chemotherapy. Method of measurement: Real-time polymerase chain reaction (real-time PCR). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHoma davoodi
Gorgan University of Medical Sciences
Outcome results
None listed