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

Damanhour University

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT04166253

919PP17

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Control group

No Intervention group

Description:

Control group of breast cancer patients will receive adjuvant AC chemotherapy

Vitamin D group

Experimental group

Description:

Intervention group of breast cancer patients will receive adjuvant AC chemotherapy in addition to vitamin D (alfacalcidol 0.5 mcg orally once daily

Treatment:

Drug: Vitamin D