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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Vitamin D

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 (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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Beheira, Egypt, 22511
    • Damnhour University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control group; Control group of breast cancer patients will receive adjuvant AC chemotherapy
EXPERIMENTAL: Vitamin D group; Intervention group of breast cancer patients will receive adjuvant AC chemotherapy in addition to vitamin D (alfacalcidol 0.5 mcg orally once daily	Drug: Vitamin D; Alfacalcidol oral tablets once daily; Other Names: Alfacalcidol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Troponin-T in ng/l	A change in plasma levels of Troponin-T in ng/l	3 months
Vitamin D in ng/ml	A change in plasma levels of Vitamin D in ng / ml	3 months
LDH in U/L	A change in plasma levels of LDH in U/L	3 months
Interleukin-6 in MIU/ml	A change in plasma levels of Interleukin-6 in MIU/ ml	3 months

Collaborators and Investigators

• Sponsor: Damanhour University
• Investigators: Study Director: Maged W Helmy, PhD, Professor of Pharmacology, Faculty of pharmacy, Damanhour University; Study Director: Gehan A Khedr, PhD, Assistant Professor of Oncology, Faculty of Medicine, Alexandria University; Study Director: Noha A El Bassiouny, PhD, Lecturer of Clinical Pharmacy, Faculty of Pharmacy, Damanhour University; Principal Investigator: Mostafa A Mahmoud, PharmD, Clinical Pharmacy Specialist

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2019
• Primary Completion (ACTUAL): April 1, 2020
• Study Completion (ACTUAL): May 1, 2020

Study Registration Dates

• First Submitted: November 11, 2019
• First Submitted That Met QC Criteria: November 15, 2019
• First Posted (ACTUAL): November 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 3, 2021
• Last Update Submitted That Met QC Criteria: February 2, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D; Alfacalcidol
• Other Study ID Numbers: 919PP17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Summary of data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes