Breast Cancer
Conditions
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. 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.
Interventions
DRUGVitamin D
Alfacalcidol oral tablets once daily
Sponsors
Damanhour University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
The participant did not know the exact drug he is using.
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
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Troponin-T in ng/l | 3 months | A change in plasma levels of Troponin-T in ng/l |
| Vitamin D in ng/ml | 3 months | A change in plasma levels of Vitamin D in ng / ml |
| LDH in U/L | 3 months | A change in plasma levels of LDH in U/L |
| Interleukin-6 in MIU/ml | 3 months | A change in plasma levels of Interleukin-6 in MIU/ ml |
Countries
Egypt
Outcome results
None listed