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IRCT20230221057485N1 IRCT 2023-07-30 Gorgan University of Medical Sciences The effect of adding Desloratadine to neoadjuvant chemotherapy in patients with breast cancer Investigation of the effect of adding Desloratadine to neoadjuvant chemotherapy on the response to treatment and some of inflammatory factors in breast cancer patients 2023-08-01 anticipated 104 Complete https://irct.ir/trial/71555 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done in a stratified manner. In this way, 34 people will be selected from among the qualified people in each of the classes. Then, by a simple random method (34 similar cards are prepared and the letter A is written on 17 cards and the letter B is written on the other 17 cards, and then the patients will be randomly assigned to groups.), Blinding description: Participants (patients) who do not know their group type, control or intervention. 2 Breast cancer. 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® tablets manufactured by Abidi Company, Iran) is prescribed daily (oral) until the patient is re-examined (about 2 months). At the end of 4 chemotherapy courses (every two weeks), breast ultrasound is performed again to evaluate the treatment response. then blood samples (7-10 cc) are taken and the amount of cytokines and gene expression changes in peripheral blood mononuclear cells are measured. Intervention 2: Control group: Control group: 52 patients with breast cancer are randomly included in the control group, this group is subjected to neoadjuvant chemotherapy (anthracyline base drugs) and prescribed until the patient's re-examination (about 2 months). At the end of 4 courses of chemotherapy (every two weeks), breast ultrasound is performed again to evaluate the treatment response, blood samples of the patients at the beginning and at the end of the study (2 months after the start of the treatment course) were taken in the amount of 7-10 cc and the amount cytokines and gene expression changes are measured in peripheral blood mononuclear cells. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The patients' information is confidential, and the results of the analysis and review of the patients' information will be published in the form of articles in reputable scientific journals.
public Homa davoodi
Mina Gol Complex, 97 Edalat, Valiasr St.
Gorgan Iran (Islamic Republic of) 4917943760 +98 17 3255 7487 drdavoodi@goums.ac.ir Gorgan University of Medical Sciences scientific Reza Khandozi
Unit 44, 4th Floor, Villa Building, 21 Adalat St., Valiasr Street.
Gorgan Iran (Islamic Republic of) 4934174515 +98 17 3255 7487 drkhandoozi۹۲۰۰۲@yahoo.com Gorgan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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 18 years no limit Female Patients with immunological disorders Patients who are not eligible for chemotherapy Patients who have undergone breast surgery C50 Malignant neoplasm of breast Treatment - Drugs Treatment - Drugs Intervention group: 52 patients with breast cancer are randomly included in the intervention group. In addition to the neoadjuvant chemotherapy process, desloratadine 5mg (Neotadine® tablets manufactured by Abidi Company, Iran) is prescribed daily (oral) until the patient is re-examined (about 2 months). At the end of 4 chemotherapy courses (every two weeks), breast ultrasound is performed again to evaluate the treatment response. then blood samples (7-10 cc) are taken and the amount of cytokines and gene expression changes in peripheral blood mononuclear cells are measured. Control group: Control group: 52 patients with breast cancer are randomly included in the control group, this group is subjected to neoadjuvant chemotherapy (anthracyline base drugs) and prescribed until the patient's re-examination (about 2 months). At the end of 4 courses of chemotherapy (every two weeks), breast ultrasound is performed again to evaluate the treatment response, blood samples of the patients at the beginning and at the end of the study (2 months after the start of the treatment course) were taken in the amount of 7-10 cc and the amount cytokines and gene expression changes are measured in peripheral blood mononuclear cells. 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. 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). Gorgan University of Medical Sciences Approved 2023-07-24 Ethics committee of Golestan University of Medical Sciences Golestan University of Medical Sciences, Shasat Kala road, Hirkan Blvd, Gorgan Gorgan Golestan Iran (Islamic Republic of)