Protective Role of Vitamin D in Breast Cancer Patients Treated With Doxorubicin (VDDOXO)
Primary Purpose
Breast Cancer
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Vitamin D
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer
Eligibility Criteria
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.
Sites / Locations
- Damnhour university
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
Vitamin D group
Arm Description
Control group of breast cancer patients will receive adjuvant AC chemotherapy
Intervention group of breast cancer patients will receive adjuvant AC chemotherapy in addition to vitamin D (alfacalcidol 0.5 mcg orally once daily
Outcomes
Primary Outcome Measures
Troponin-T in ng/l
A change in plasma levels of Troponin-T in ng/l
Vitamin D in ng/ml
A change in plasma levels of Vitamin D in ng / ml
LDH in U/L
A change in plasma levels of LDH in U/L
Interleukin-6 in MIU/ml
A change in plasma levels of Interleukin-6 in MIU/ ml
Secondary Outcome Measures
Full Information
NCT ID
NCT04166253
First Posted
November 11, 2019
Last Updated
February 2, 2021
Sponsor
Damanhour University
1. Study Identification
Unique Protocol Identification Number
NCT04166253
Brief Title
Protective Role of Vitamin D in Breast Cancer Patients Treated With Doxorubicin
Acronym
VDDOXO
Official Title
The Potential Protective Effects of Vitamin (D) Against Doxorubicin Induced Cardiotoxicity in Breast Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
May 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Damanhour University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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:
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.
Echocardiography (Echo) will be done 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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
2 arms one is a control arm recieving only doxorubucin adjuvant chemotherapy and another intervention arm recieving doxorubucin as well as vitamin D orally once daily for 3 months
Masking
Participant
Masking Description
The participant did not know the exact drug he is using.
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control group of breast cancer patients will receive adjuvant AC chemotherapy
Arm Title
Vitamin D group
Arm Type
Experimental
Arm Description
Intervention group of breast cancer patients will receive adjuvant AC chemotherapy in addition to vitamin D (alfacalcidol 0.5 mcg orally once daily
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Other Intervention Name(s)
Alfacalcidol
Intervention Description
Alfacalcidol oral tablets once daily
Primary Outcome Measure Information:
Title
Troponin-T in ng/l
Description
A change in plasma levels of Troponin-T in ng/l
Time Frame
3 months
Title
Vitamin D in ng/ml
Description
A change in plasma levels of Vitamin D in ng / ml
Time Frame
3 months
Title
LDH in U/L
Description
A change in plasma levels of LDH in U/L
Time Frame
3 months
Title
Interleukin-6 in MIU/ml
Description
A change in plasma levels of Interleukin-6 in MIU/ ml
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maged W Helmy, PhD
Organizational Affiliation
Professor of Pharmacology, Faculty of pharmacy, Damanhour University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Gehan A Khedr, PhD
Organizational Affiliation
Assistant Professor of Oncology, Faculty of Medicine, Alexandria University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Noha A El Bassiouny, PhD
Organizational Affiliation
Lecturer of Clinical Pharmacy, Faculty of Pharmacy, Damanhour University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mostafa A Mahmoud, PharmD
Organizational Affiliation
Clinical Pharmacy Specialist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Damnhour university
City
Beheira
ZIP/Postal Code
22511
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Summary of data
Learn more about this trial
Protective Role of Vitamin D in Breast Cancer Patients Treated With Doxorubicin
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