Clincosm LogoSign in Get a demo

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

Sponsor
Damanhour University (Other)
Overall Status
Completed
CT.gov ID
NCT04166253
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
8
Actual Duration (Months)
12.5
Patients Per Site Per Month

Study Details

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:
  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.

  1. Echocardiography (Echo) will be done at base line and at the end of the treatment.

  2. Vitamin D, LDH, Troponin-t as well as IL-6 will be assessed at baseline and at the end of the study.

Condition or Disease Intervention/Treatment Phase
  • Drug: Vitamin D
 Phase 2

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.

  1. 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.

  2. Tumor staging is done according to American joint committee on cancer (TNM staging of breast cancer eighth edition (Amin et al., 2017).

  3. 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.

  1. Echocardiography (Echo) at base line and at the end of the treatment.

  2. 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 Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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 months2 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:
Single (Participant)
Masking Description:
The participant did not know the exact drug he is using.
Primary Purpose:
Supportive Care
Official Title:
The Potential Protective Effects of Vitamin (D) Against Doxorubicin Induced Cardiotoxicity in Breast Cancer Patients
Actual Study Start Date :
Sep 1, 2019
Actual Primary Completion Date :
Apr 1, 2020
Actual Study Completion Date :
May 1, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Troponin-T in ng/l [3 months]

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

    2. Vitamin D in ng/ml [3 months]

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

    3. LDH in U/L [3 months]

      A change in plasma levels of LDH in U/L

    4. Interleukin-6 in MIU/ml [3 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 65 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Damnhour university Beheira Egypt 22511

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Noha El Bassiouny, Lecturer of clinical pharmacy, Damanhour University
    ClinicalTrials.gov Identifier:
    NCT04166253
    Other Study ID Numbers:
    • 919PP17
    First Posted:
    Nov 18, 2019
    Last Update Posted:
    Feb 3, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Breast Neoplasms
    Vitamin D
    Alfacalcidol

    Study Results

    No Results Posted as of Feb 3, 2021