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

Breast Cancer Clinical Trial

— VDDOXO  

Official title:

The Potential Protective Effects of Vitamin (D) Against Doxorubicin Induced Cardiotoxicity in Breast Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04166253
• Other study ID #: 919PP17
• Status: Completed
• Phase: Phase 2
• Start date: September 1, 2019
• Est. completion date: May 1, 2020

Study information

• Verified date: February 2021
• Source: Damanhour University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 (i.e. 3 months.)

2. 100 Patients 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients has a good performance status (ECOG 0-2) according to eastern cooperative oncology group (ECOG) score.

• Adequate complete blood picture patients.

• Females from (30-65) years of old.

• Normal renal and liver functions.

Exclusion criteria:

• Cardiac diseased or reduced cardiac output with left ventricular ejection fraction less than 50%.

• Hepatic impaired patients.

• Pregnancy or breast feeding or child bearing state.

• Patient with history of allergy to vitamin D.

• Concomitant use of other vitamins.

• Renal impaired patients.

• History of breast cancer.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Vitamin D
Alfacalcidol oral tablets once daily

Locations

Country	Name	City	State
Egypt	Damnhour university	Beheira

Sponsors (1)

Lead Sponsor	Collaborator
Damanhour University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Troponin-T in ng/l	A change in plasma levels of Troponin-T in ng/l	3 months
Primary	Vitamin D in ng/ml	A change in plasma levels of Vitamin D in ng / ml	3 months
Primary	LDH in U/L	A change in plasma levels of LDH in U/L	3 months
Primary	Interleukin-6 in MIU/ml	A change in plasma levels of Interleukin-6 in MIU/ ml	3 months