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Prophylaxis of Hematologic Complications With Naderin in First-Line Breast Cancer Chemotherapy (NADERIN-BC)

2026년 6월 26일 업데이트: MIPO Clinic

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:

  1. Does taking Naderin lower the number of people who get low white blood cell counts during chemotherapy?
  2. 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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

79

단계

  • 2 단계
  • 3단계

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
의약품: Naderin
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.
다른 이름들:
  • Sodium Deoxyribonucleate
  • Sodium nucleinate
활성 비교기: 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.
의약품: AC Chemotherapy
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
다른 이름들:
  • 독소루비신 및 시클로포스파미드

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Incidence of leukopenia during chemotherapy
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Chemotherapy completion rate
기간: 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.
At the end of treatment, up to 4 months
Rate of chemotherapy interruption
기간: Through chemotherapy completion, up to 4 months
Proportion of participants requiring chemotherapy interruption, dose delay, or premature discontinuation due to hematologic complications or other adverse events.
Through chemotherapy completion, up to 4 months
Requirement for colony-stimulating factors
기간: 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.
Through chemotherapy completion, up to 4 months
All-cause mortality
기간: Through study completion, up to 12 months
Proportion of participants who died from any cause during the study period.
Through study completion, up to 12 months
Quality of Life assessment
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

MIPO Clinic

협력자

Asfendiyarov Kazakh National Medical University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2014년 1월 1일

기본 완료 (실제)

2015년 12월 31일

연구 완료 (실제)

2016년 12월 1일

연구 등록 날짜

최초 제출

2026년 6월 22일

QC 기준을 충족하는 최초 제출

2026년 6월 22일

처음 게시됨 (실제)

2026년 6월 26일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 30일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 26일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 7
  • Grant of KazNMU 2012 (기타 보조금/기금 번호: KazNMU)

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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