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Completed

NCT Number: NCT04166253

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

30 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Damnhour university

Beheira, 22511, Egypt

About this study

Research Objectives: Evaluation of the potential protective effect of Vitamin D in doxorubucin- induced toxicity in breast cancer patients.

Proposal Steps:

  • 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.)
  • 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.
  • 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.
  • Tumor staging is done according to American joint committee on cancer (TNM staging of breast cancer eighth edition (Amin et al., 2017).
  • 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.
  • Echocardiography (Echo) at base line and at the end of the treatment.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin D

Drug

Alfacalcidol oral tablets once daily

Other names: Alfacalcidol

Primary outcomes

  1. Troponin-T in ng/l

    Time frame: 3 months

    A change in plasma levels of Troponin-T in ng/l

  2. Vitamin D in ng/ml

    Time frame: 3 months

    A change in plasma levels of Vitamin D in ng / ml

  3. LDH in U/L

    Time frame: 3 months

    A change in plasma levels of LDH in U/L

  4. Interleukin-6 in MIU/ml

    Time frame: 3 months

    A change in plasma levels of Interleukin-6 in MIU/ ml

Sponsors and collaborators

Lead sponsor

Damanhour University

Other

Registry information

Official study title

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

Acronym: VDDOXO

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 18, 2019
Registry last updated
Feb 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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