Protein and Calorie Restriction as Treatment for Prevention of Cardiotoxicity in Women Receiving Chemotherapy.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- High-sensitivity troponin T (hsTnT)
研究概览
简要总结
The goal of this clinical trial is to compare a dietary intervention with a regular diet in patients with early breast cancer undergoing anthracycline based chemotherapy. The main question it aims to answer is:
What are the effects of a short-term diet with 30% caloric and 70% protein restriction (PCR) on cardiotoxicity induced by anthracycline treatment in women with newly diagnosed invasive breast cancer.
Researchers will compare the control group with dietary intervention group to see if cardiotoxicity -measured by concentrations of high-sensitivity troponin T (hsTnT) levels- will be different between these two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women with newly diagnosed triple negative breast cancer with an indication for (neo-)adjuvant ATC-based chemotherapy and of intent to start anticancer treatment;
- •age between 18 and 75 years;
- •written informed consent;
- •body mass index ≥ 19.
排除标准
- •Allergic to any of the ingredients of the diet;
- •Known history of cardiac dysfunction;
- •Severe morbidity with the inability to receive anticancer treatment.
- •Participation in another clinical trial with an intervention arm (database and/or biobank studies excluded);
- •Pregnant women
- •Previous treatment with anthracycline
- •Estrogen receptor positive status
结局指标
主要结局
High-sensitivity troponin T (hsTnT)
时间窗: Bloodsamples will be taken before and 1 hour after each anthracycline based chemotherapy cycle. The cycles are given once every 2 weeks, for 4 cycles in total.
Cardiotoxicity as determined by the difference in concentrations of high-sensitivity troponin T (hsTnT) levels after protein and calorie restriction and anthracycline treatment in one cycle, delta HsTnT (Δ HsTnT).
次要结局
- Left ventricular ejection fraction and global longitudinal (LVEF and GLS)(6 months and 12 months after start of anthracycline therapy)
- Creatine kinase(Bloodsamples will be taken before and 1 hour after each anthracycline cycle. The cycles are given once every 2 weeks, for 4 cycles in total.)
- Effect of dietary intervention on tumor volume/response(After chemotherapy cycle 3 or cycle 4 (chemotherapy is given every 2 weeks))
- Metabolic parameters(Bloodsamples will be taken before and 1 hour after each anthracycline based chemotherapy cycle. The cycles are given once every 2 weeks, for 4 cycles in total.)
- Other anthracycline-related toxicities(After each anthracycline based chemotherapy cycle, which is given every 2 weeks. There will be 4 cycles in total.)
- Effect of dietary intervention on pharmacokinetics of anthracycline(Bloodsamples will be taken before and 1 hours after each anthracycline based chemotherapy cycle. The cycles are given once every 2 weeks, for 4 cycles in total.)
- Troponin levels(Bloodsamples will be taken before and 1 hour after each anthracycline based chemotherapy cycle. The cycles are given once every 2 weeks, for 4 cycles.)
- Brain natriuretic peptide (NT-proBNP)(Bloodsamples will be taken before and 1 hour after each anthracycline based chemotherapy cycle. The cycles are given once every 2 weeks, for 4 cycles in total.)
- Subjective wellbeing(During each anthracycline chemotherapy cycle. The chemotherapy is given every 2 weeks, in total 4 cycles. Then 6 months and 12 months after start of anthracycline therapy questionnaires will be taken again.)
研究者
Franny Jongbloed
Principal Investigator
Erasmus Medical Center