NCT04166253已完成2 期
The Potential Protective Effects of Vitamin (D) Against Doxorubicin Induced Cardiotoxicity in Breast Cancer Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Troponin-T in ng/l
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
The participant did not know the exact drug he is using.
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
研究组 & 干预措施
Vitamin D group
Experimental
Intervention group of breast cancer patients will receive adjuvant AC chemotherapy in addition to vitamin D (alfacalcidol 0.5 mcg orally once daily
干预措施: Vitamin D (Drug)
结局指标
主要结局
Troponin-T in ng/l
时间窗: 3 months
A change in plasma levels of Troponin-T in ng/l
Interleukin-6 in MIU/ml
时间窗: 3 months
A change in plasma levels of Interleukin-6 in MIU/ ml
Vitamin D in ng/ml
时间窗: 3 months
A change in plasma levels of Vitamin D in ng / ml
LDH in U/L
时间窗: 3 months
A change in plasma levels of LDH in U/L
次要结局
未报告次要终点
研究者
Noha El Bassiouny
Lecturer of clinical pharmacy
Damanhour University
研究点 (1)
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