Prophylaxis of Hematologic Complications With Naderin in First-Line Breast Cancer Chemotherapy

This was a prospective, open-label, interventional study conducted at the Kazakh Scientific Research Institute of Oncology and Radiology in Almaty, Republic of Kazakhstan, in collaboration with KazNMU and the Almaty Oncology Center. The study evaluated the prophylactic use of Naderin during first-line AC chemotherapy for breast cancer. Participant Allocation: A total of 79 participants with breast cancer receiving first-line chemotherapy were enrolled and assigned to two groups. The main group, consisting of 38 participants, received AC chemotherapy with Naderin as an adjunct prophylactic agent. The control group, consisting of 41 participants, received AC chemotherapy alone. Allocation was not randomized; participants were assigned based on consecutive enrollment according to clinical availability and patient consent. Intervention Details: All participants received standard AC chemotherapy consisting of doxorubicin and cyclophosphamide administered intravenously for 4 planned cycles at standard institutional dosing. Participants in the main group additionally received Naderin, a sodium deoxyribonucleate immunomodulatory agent, administered locally alongside each chemotherapy cycle. Naderin functions by activating cellular and humoral immunity, stimulating reparative processes, and exhibiting anti-inflammatory properties. Outcome Measures: The primary outcome was the incidence of leukopenia, defined as white blood cell count below the institutional lower limit of normal, measured by complete blood counts during chemotherapy cycles. Secondary outcomes included completion rate of all 4 planned chemotherapy cycles, need for chemotherapy interruption or discontinuation, requirement for colony-stimulating factor administration, quality of life assessment using a validated instrument, and all-cause mortality during the study period. Assessment Schedule: At baseline, participants underwent complete blood count, medical history documentation, and quality of life assessment. During each of the 4 chemotherapy cycles, complete blood counts were performed and adverse events were monitored. At the end of treatment, complete blood count, quality of life assessment, and treatment completion status were recorded. Follow-up included survival status documentation. Statistical Analysis: The primary comparison between groups for leukopenia incidence was performed using the chi-square test with a significance level set at p \< 0.05. Ethical Considerations: The study was conducted in accordance with the Declaration of Helsinki. Institutional review board approval was obtained, and all participants provided written informed consent prior to enrollment.