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

26 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Effettivo)

79

Fase

  • Fase 2
  • Fase 3

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Droga: 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.
Altri nomi:
  • Sodium Deoxyribonucleate
  • Sodium nucleinate
Comparatore attivo: 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.
Droga: 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
Altri nomi:
  • Doxorubicina e ciclofosfamide

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of leukopenia during chemotherapy
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Chemotherapy completion rate
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

MIPO Clinic

Collaboratori

Asfendiyarov Kazakh National Medical University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 gennaio 2014

Completamento primario (Effettivo)

31 dicembre 2015

Completamento dello studio (Effettivo)

1 dicembre 2016

Date di iscrizione allo studio

Primo inviato

22 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

22 giugno 2026

Primo Inserito (Effettivo)

26 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

30 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

26 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 7
  • Grant of KazNMU 2012 (Altro numero di sovvenzione/finanziamento: KazNMU)

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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