Prophylaxis of Hematologic Complications With Naderin in First-Line Breast Cancer Chemotherapy (NADERIN-BC)
Medical Rehabilitation in Oncology: Prophylaxis of Hematologic and Immunologic Complications Using Naderin During First-Line Chemotherapy of Breast Cancer
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Assessments and Follow-up
Participants underwent:
Baseline evaluation prior to chemotherapy initiation, including clinical assessment and laboratory testing.
On-treatment monitoring during each AC cycle with serial complete blood counts and structured adverse-event assessment.
End-of-treatment evaluation after completion of planned chemotherapy cycles (or earlier discontinuation), including laboratory reassessment and documentation of chemotherapy delivery (cycle completion, delays, interruptions).
Outcomes (high-level; details recorded elsewhere) The study evaluated hematologic toxicity during chemotherapy and chemotherapy delivery feasibility (ability to complete planned cycles without interruption), along with safety/tolerability of adjunctive Naderin.
Statistical Approach (high-level) The primary between-group comparison for hematologic toxicity incidence was planned using categorical testing (chi-square) with a two-sided alpha threshold of 0.05, with descriptive summaries of chemotherapy delivery metrics and adverse events.
Ethical and Oversight Considerations The study was approved by the Local Ethics Committee of KazNMU (Approval No. 15677). Written informed consent was obtained from all participants prior to enrollment. No independent data monitoring committee was used.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
- Fase 3
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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.
|
Naderin is an immunomodulatory agent containing sodium deoxyribonucleate.
It activates cellular and humoral immunity, stimulates reparative processes, and exhibits anti-inflammatory properties.
It is administered locally alongside each chemotherapy cycle as prophylaxis against hematologic and immunologic complications.
The agent is rapidly absorbed upon administration, distributed through lymphatic pathways to organs and tissues, and excreted primarily via the kidneys.
Outros nomes:
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Comparador Ativo: 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.
|
Standard first-line chemotherapy regimen consisting of doxorubicin (an anthracycline antibiotic) and cyclophosphamide (an alkylating agent).
Administered intravenously for 4 cycles at standard institutional dosing.
This is the backbone chemotherapy regimen for both study arms, with the experimental arm receiving Naderin as an adjunct prophylactic agent
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Incidence of leukopenia during chemotherapy
Prazo: 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)
|
Through chemotherapy completion, up to 4 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Chemotherapy completion rate
Prazo: At the end of treatment, up to 4 months
|
Proportion of participants who successfully complete all 4 planned cycles of AC chemotherapy without interruption, dose reduction, or premature discontinuation.
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At the end of treatment, up to 4 months
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Rate of chemotherapy interruption
Prazo: Through chemotherapy completion, up to 4 months
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Proportion of participants requiring chemotherapy interruption, dose delay, or premature discontinuation due to hematologic complications or other adverse events.
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Through chemotherapy completion, up to 4 months
|
|
Requirement for colony-stimulating factors
Prazo: Through chemotherapy completion, up to 4 months
|
Proportion of participants requiring administration of granulocyte colony-stimulating factors (G-CSF) for management of chemotherapy-induced neutropenia.
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Through chemotherapy completion, up to 4 months
|
|
All-cause mortality
Prazo: Through study completion, up to 12 months
|
Proportion of participants who died from any cause during the study period.
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Through study completion, up to 12 months
|
|
Quality of Life assessment
Prazo: Baseline and at end of treatment, up to 4 months
|
Change from baseline to end of chemotherapy in Global Health Status/Quality of Life (GHS/QoL) using EORTC QLQ-C30 (version 3.0).
Scores are transformed to a 0-100 scale; higher scores indicate better QoL for GHS/QoL and functioning scales (and worse symptoms for symptom scales-if reported).
|
Baseline and at end of treatment, up to 4 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Citopenia
- Neoplasias por local
- Neoplasias
- Distúrbios leucocitários
- Doenças de pele
- Doenças da mama
- Doenças da Pele e do Tecido Conjuntivo
- Doenças hemic e linfáticas
- Neoplasias da Mama
- Doenças Hematológicas
- Leucopenia
- Produtos químicos orgânicos
- Hidrocarbonetos
- Hidrocarbonetos, cíclicos
- Carboidratos
- Hidrocarbonetos aromáticos policíclicos
- Hidrocarbonetos, aromáticos
- Compostos policíclicos
- Glicosídeos
- Mustarazas de fosforamida
- Compostos de mostarda de nitrogênio
- Compostos de mostarda
- Hidrocarbonetos, halogenados
- Fosforamidas
- Compostos organofosforos
- Antraciclinas
- Nafthacenos
- Aminoglicosídeos
- Daunorubicina
- Ciclofosfamida
- Doxorrubicina
- sodium nucleinate
Outros números de identificação do estudo
- 7
- Grant of KazNMU 2012 (Número de outro subsídio/financiamento: KazNMU)
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