Medical Rehabilitation in Oncology: Prophylaxis of Hematologic and Immunologic Complications Using Naderin During First-Line Chemotherapy of Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 79
- 主要终点
- Incidence of leukopenia during chemotherapy
研究概览
简要总结
The goal of this clinical trial is to learn if Naderin works to prevent low white blood cell counts in people with breast cancer receiving first-line chemotherapy. The main questions it aims to answer are:
- Does taking Naderin lower the number of people who get low white blood cell counts during chemotherapy?
- Does taking Naderin help people finish all of their chemotherapy treatments without interruptions? Researchers will compare people who receive chemotherapy with Naderin to people who receive chemotherapy alone to see if Naderin helps prevent low white blood cell counts.
Participants will:
Receive standard AC chemotherapy for breast cancer Either receive Naderin along with chemotherapy or receive chemotherapy alone Have regular blood tests to check white blood cell counts Complete all 4 chemotherapy cycles
Key finding: The study found that 14 out of 100 people who received Naderin developed low white blood cell counts, compared to 39 out of 100 people who did not receive Naderin.
详细描述
Study Rationale Myelosuppression and related immunologic complications are common dose-limiting toxicities of cytotoxic chemotherapy and can lead to treatment delays, dose reductions, or discontinuation. This study assessed prophylactic administration of Naderin (sodium deoxyribonucleate; immunomodulatory agent) as supportive care during first-line AC chemotherapy, with the intent to mitigate hematologic toxicity and preserve chemotherapy delivery.
Study Design and Setting This was a prospective, open-label, two-group interventional study conducted at the Kazakh Scientific Research Institute of Oncology and Radiology (Almaty, Kazakhstan) in collaboration with KazNMU and the Almaty Oncology Center. Treatment allocation was non-randomized and based on consecutive enrollment, treatment availability, and participant consent.
Study Groups and Interventions Control group: standard institutional AC chemotherapy (doxorubicin + cyclophosphamide), intravenous administration, 4 planned cycles.
Intervention group: the same AC chemotherapy regimen plus Naderin administered as a prophylactic adjunct with each chemotherapy cycle (route and dosing per local institutional protocol).
Concomitant medications and supportive care (including any antiemetics, antimicrobials, or use of colony-stimulating factors) were permitted according to institutional practice and recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants and care providers were aware of the treatment assignments. However, the outcomes assessor performing the final analysis of leukopenia incidence was blinded to the allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Confirmed histological diagnosis of breast cancer
- •Receiving first-line AC chemotherapy (doxorubicin + cyclophosphamide)
- •Age 18 years or older
- •Female sex
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Adequate bone marrow function (absolute neutrophil count ≥ 1.5 × 10⁹/L, platelet count ≥ 100 × 10⁹/L)
- •Adequate hepatic function (transaminases ≤ 2.5 × upper limit of normal)
- •Adequate renal function (creatinine ≤ 1.5 × upper limit of normal)
- •Normal cardiac function (left ventricular ejection fraction ≥ 50%)
- •Willing and able to provide written informed consent
排除标准
- •Previous chemotherapy or radiotherapy for breast cancer
- •History of other malignant neoplasms (except non-melanoma skin cancer or carcinoma in situ of the cervix)
- •Severe organ dysfunction (cardiac, hepatic, renal, pulmonary)
- •Active infection requiring systemic therapy
- •Known hypersensitivity to Naderin or any of its components
- •Known hypersensitivity to doxorubicin, cyclophosphamide, or any excipients
- •Pregnancy or breastfeeding
- •Psychiatric or cognitive impairment that would interfere with study participation
- •Participation in another interventional clinical trial within 30 days prior to enrollment
- •Any condition that, in the investigator's opinion, would compromise participant safety or interfere with study objectives
研究组 & 干预措施
Naderin prophylaxis Group
Participants in this arm receive standard first-line AC chemotherapy (doxorubicin + cyclophosphamide) for 4 cycles. In addition, participants receive Naderin (sodium deoxyribonucleate) as an adjunct prophylactic agent administered locally alongside each chemotherapy cycle to prevent hematologic and immunologic complications.
干预措施: Naderin (Drug)
Chemotherapy alone Group
Participants in this arm receive standard first-line AC chemotherapy (doxorubicin + cyclophosphamide) for 4 cycles. Participants do not receive Naderin or any other prophylactic immunomodulatory agent. This group serves as the active comparator to evaluate the prophylactic effect of Naderin on hematologic complications.
干预措施: AC Chemotherapy (Drug)
结局指标
主要结局
Incidence of leukopenia during chemotherapy
时间窗: Through chemotherapy completion, up to 4 months
Proportion of participants who develop leukopenia (white blood cell count below the institutional lower limit of normal) during any of the 4 chemotherapy cycles. Leukopenia is defined as a decrease in circulating white blood cells below 4.0 × 10⁹/L (or per institutional laboratory reference range)
次要结局
- Chemotherapy completion rate(At the end of treatment, up to 4 months)
- Rate of chemotherapy interruption(Through chemotherapy completion, up to 4 months)
- Requirement for colony-stimulating factors(Through chemotherapy completion, up to 4 months)
- All-cause mortality(Through study completion, up to 12 months)
- Quality of Life assessment(Baseline and at end of treatment, up to 4 months)