drugset / Trial / NCT07671547

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

NCT07671547

RandomizedParallel-groupSingle-blindPrevention

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Cholecalciferol Other / unclassified Other
Comparator Cyclophosphamide Other / unclassified Intravenous
Comparator Doxorubicin Other / unclassified Intravenous