Viewing Study NCT04166253



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Last Modification Date: 2024-10-26 @ 1:22 PM
Study NCT ID: NCT04166253
Status: COMPLETED
Last Update Posted: 2021-02-03
First Post: 2019-11-11

Brief Title: Protective Role of Vitamin D in Breast Cancer Patients Treated With Doxorubicin
Sponsor: Damanhour University
Organization: Damanhour University

Study Overview

Official Title: The Potential Protective Effects of Vitamin D Against Doxorubicin Induced Cardiotoxicity in Breast Cancer Patients
Status: COMPLETED
Status Verified Date: 2021-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: VDDOXO
Brief 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 n50 the patient will receive AC regimen Doxorubucin cyclophosphamide for 4 cycles every 21 day ie 3 months
Vitamin D group n50 who will receive 4 Cycles AC regimen in addition to vitamin D Bon One 05 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
Detailed Description: Research Objectives Evaluation of the potential protective effect of Vitamin D in doxorubucin- induced toxicity in breast cancer patients

Proposal Steps

1 Assessing breast cancer patients taking part in the study receiving adjuvant chemotherapy AC Anthracycline Doxorubucin-cyclophosphamide for breast cancer for 4 cycles every 21 day ie 3 months
2 100 Patients are randomly assigned in to two groups

Control group n50 the patient will receive AC regimen Doxorubucin Cyclophosphamide for 4 cycles every 21 day ie 3 months
Vitamin D group n50 who will receive 4 Cycles AC regimen in addition to vitamin D once daily
3 All participants are recruited from AMUH Hospital Oncology Unit All participants will be given their consent The study will be approved by research ethics committee of Damanhour University
4 Tumor staging is done according to American joint committee on cancer TNM staging of breast cancer eighth edition Amin et al 2017
5 All patients will be submitted to

Full patient history and clinical examination
Routine follow up before and after each chemotherapy cycle complete blood picture liver function tests renal function tests
6 Echocardiography Echo at base line and at the end of the treatment
7 Vitamin D LDH Troponin-t as well as IL-6 will be assessed at baseline and at the end of the study

Methodology

Venous blood samples will be analyzed using ELISA Vitamin D IL-6 kits and immuno-histo-chemistry Troponoin-T and LDH and kits

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: True
Is an FDA AA801 Violation?: None