Anti-Inflammatory Dietary Intervention in Breast Cancer Patients Receiving Aromatase Inhibitors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- Nutritional status
研究概览
简要总结
This project aims to decrease undesirable side effects and increase qulaity of life of aromatase inhibitors therapy in breast cancer survivors, by anti-inflammatory diet or supplementation.
详细描述
With 2.1 million new breast cancer (BRC) cases each year globally, BRC is one of the biggest health challenges today. Available anticancer therapies have limited efficacy and are coupled with toxic side effects. Nutritional intervention can ameliorate undesirable effects, reduce exhaustion, psychological harm, and costs spent on treating these side effects. The proposed project AID aims to improve clinical outcome, quality of life (QoL) and survival rate in BRC patients on adjuvant endocrine therapy with aromatase inhibitors (AI) by nutritional interventions. In a three-arm randomised controlled nutritional trial involving 90 BRC patients who will receive either supplement or placebo pills (control group), or an anti-inflammatory diet for 4 months, along with the AI therapy, changes in nutritional status, QoL, biochemical and clinical parameters will be measured in comparison among three groups. The second goal is to establish cause-and-effect relationships among the clinical outcomes, nutritional status and biochemical parameters related to cancer, including inflammatory and redox status, plasma lipidome and polymorphism of fatty acid desaturase (FADS) genes. Introducing an effective nutritional intervention in BRC patients as an integral part of the multimodal therapeutic approach is the goal of this project.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Placebo capusuls will be identical as supplement
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age: 45 to 70 years
- •Postmenopausal women
- •Histologically confirmed BRC, stage I to IIIa
- •ER positive /HER2 negative
- •Application of adjuvant hormone therapy with aromase inhibitors: 6 to 30 months
- •Body mass index from 20 to 34.9 kg/m 2
- •Able to understand the requirements of the study and provide written information consent
排除标准
- •Metastatic or locally advanced disease
- •HER2-positive tumors
- •Presence of other malignant or serious chronic diseases
- •Active infections
- •Previous stroke or heart attack,
- •Rheumatoid arthritis and other types of autoimmune diseases
- •Presence of a significant neurological deficit
- •Allergy to the ingredients of the dietary preparation or to fish, fish oil and nuts fruits.
- •Allergies to evening primrose oil or other oils containing gamma-linolenic acid (borage, black currant)
- •Use of lipid-lowering drugs (statins, Normolip)
- •Current use of warfarin or other anticoagulants
- •Corticosteroid therapy for the last month
- •Use of dietary supplements based on fish oil, evening primrose, and flaxseed oils, omega 3-6-9 fatty acids, multivitamins with added omega-3 of fatty acids 3 months before the start of the study
结局指标
主要结局
Nutritional status
时间窗: baseline, 4 months, 1 year
assessed through blood cells count
Changes in Quality of life
时间窗: baseline, 4 months
assessed through the questionnaires FACT ES. The response scale is 5 point Likert-type scale (0- not at all, 4- very much).
Clinical outcome
时间窗: baseline, 4 months, 1 year
assessed through Laboratory analyses including BRC marker CA 15-3
次要结局
- Fatty acid status(baseline, 4 months)
- Inflammatory status(baseline, 4 months,)
- leptin and adiponectin(baseline, 4 months)
- Lipidomic analysis(baseline, 4 months)
- FADS1/FADS2(baseline)
- Redox status(baseline, 4 months,)
研究者
Vesna Vucic
Principal Investigator
University of Belgrade