Protective Role of Vitamin D in Breast Cancer Patients Treated With Doxorubicin
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

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.
    

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.
    

Intervention name(s): Vitamin D
Intervention type(s): Drug
Intervention description(s): Alfacalcidol oral tablets once daily
Other intervention name(s): Alfacalcidol
Intervention MeSH terms: Vitamin D; Alfacalcidol
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 months
Masking: Single (Participant)
Primary purpose: Supportive Care