drugset / Trial / NCT04166253

Protective Role of Vitamin D in Breast Cancer Patients Treated With Doxorubicin

NCT04166253

Phase 2 Completed 100 enrolled Damanhour University
RandomizedParallel-groupSingle-blindSupportive care

Summary

The study is aimed at Evaluation of the potential protective effect of Vitamin D in doxorubucin- induced toxicity in breast cancer patients. Proposal Steps: 1. 100 Patients recruited from Alexandria Main University Hospital (AMUH), Oncology Unit are randomly assigned in to two groups: * Control group (n=50) the patient will receive AC regimen (Doxorubucin \& cyclophosphamide) for 4 cycles every 21 day (i.e. 3 months.) * Vitamin D group (n=50) who will receive 4 Cycles AC regimen in addition to vitamin D (Bon One 0.5 microgram®) once daily. 2. Echocardiography (Echo) will be done at base line and at the end of the treatment. 3. Vitamin D, LDH, Troponin-t as well as IL-6 will be assessed at baseline and at the end of the study.

Timeline

Start
2019-09-01
Primary completion
2020-04-01
Completion
2020-05-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Alfacalcidol Other / unclassified 0.5 ug Oral

Indications