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

NCT04166253 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-02-03

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Vitamin D

Alfacalcidol oral tablets once daily

Sponsors & Collaborators

  • Damanhour University

    lead OTHER

Principal Investigators

  • Maged W Helmy, PhD · Professor of Pharmacology, Faculty of pharmacy, Damanhour University

  • Gehan A Khedr, PhD · Assistant Professor of Oncology, Faculty of Medicine, Alexandria University

  • Noha A El Bassiouny, PhD · Lecturer of Clinical Pharmacy, Faculty of Pharmacy, Damanhour University

  • Mostafa A Mahmoud, PharmD · Clinical Pharmacy Specialist

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Egypt

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Entities

Drugs
Diseases

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 NCT04166253 on ClinicalTrials.gov