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

NCT07671547 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2026-06-30

No results posted yet for this study

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. 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.

Conditions

Interventions

DRUG

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.

DRUG

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

Sponsors & Collaborators

  • Asfendiyarov Kazakh National Medical University

    collaborator OTHER

  • MIPO Clinic

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-01
Primary Completion
2015-12-31
Completion
2016-12-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07671547 on ClinicalTrials.gov