Clinical trial · Interventional
Prophylaxis of Hematologic Complications With Naderin in First-Line Breast Cancer Chemotherapy
Medical Rehabilitation in Oncology: Prophylaxis of Hematologic and Immunologic Complications Using Naderin During First-Line Chemotherapy of Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Chemotherapy-Induced Myelosuppression | — | UNRESOLVED | — |
| Hematologic Disorder | — | UNRESOLVED | — |
| Leukopenia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AC Chemotherapy | Drug | — | UNRESOLVED |
| Naderin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Naderin prophylaxis Group
- description
- 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.
- interventionNames
- Drug: Naderin
- type
- ACTIVE_COMPARATOR
- label
- Chemotherapy alone Group
- description
- 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.
- interventionNames
- Drug: AC Chemotherapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available