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

NCT07671547 | Completed Phase 2

• 2 other identifiers: 7Grant of KazNMU 2012
• Study Type: interventional
• Target: 79
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Breast Cancer; Hematologic Disorder; Leukopenia; Chemotherapy-Induced Myelosuppression

Keywords

breast cancer; chemotherapy; Naderin; leukopenia; hematological complications; immunomodulation; medical rehabilitation; prophylaxis; AC chemotherapy; sodium deoxyribonucleate

Outcome Measures

Primary Outcomes (1)

• Incidence of leukopenia during chemotherapy

  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

Secondary Outcomes (5)

• 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

• Quality of Life assessment

  Baseline and at end of treatment, up to 4 months

• All-cause mortality

  Through study completion, up to 12 months

Study Arms (2)

Naderin prophylaxis Group

EXPERIMENTAL

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.

Drug: Naderin

Chemotherapy alone Group

ACTIVE COMPARATOR

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.

Drug: AC Chemotherapy

Interventions

Naderin DRUG

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.

Also known as: Sodium Deoxyribonucleate, Sodium nucleinate

Naderin prophylaxis Group

AC Chemotherapy DRUG

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

Also known as: Doxorubicin and Cyclophosphamide

Chemotherapy alone Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MIPO Clinic: lead
• Asfendiyarov Kazakh National Medical University: collaborator

MeSH Terms

Conditions

Breast Neoplasms; Hematologic Diseases; Leukopenia

Interventions

sodium nucleinate; Doxorubicin; Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Hemic and Lymphatic Diseases; Cytopenia; Leukocyte Disorders

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are assigned to one of two parallel groups: the main group receives AC chemotherapy with Naderin, and the control group receives AC chemotherapy alone. Assignment is non-randomized based on consecutive enrollment and patient consent

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 26, 2026
• Study Start: January 1, 2014
• Primary Completion: December 31, 2015
• Study Completion: December 1, 2016
• Last Updated: June 30, 2026

Record last verified: 2026-06