Fasting-mimicking Diet: A Randomized Trial on Feasibility, Safety and Effects of Multicycle Dietary Intervention on Side Effects of Aromatase Inhibitors Treatment in Post-menopausal Patients With Breast Cancer

European Institute of Oncology1 个研究点分布在 1 个国家目标入组 60 人2024年9月1日

适应症Breast Cancer

干预措施FASTING-MIMICKING DIET PROGRAM

概览

阶段: 不适用
干预措施: FASTING-MIMICKING DIET PROGRAM
疾病 / 适应症: Breast Cancer
发起方: European Institute of Oncology
入组人数: 60
试验地点: 1
主要终点: Fasting-mimicking diet
状态: 招募中
最后更新: 2个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

The primary endpoint of this study is to determine whether cycles of short term FMD exposure to a fasting-mimicking diet is effective in reducing total cholesterol levels.

详细描述

the short term FMD exposure to a fasting-mimicking diet reduce total cholesterol levels

注册库

clinicaltrials.gov

开始日期

2024年9月1日

结束日期

2027年4月1日

最后更新

2个月前

研究类型

Interventional

研究设计

Parallel

性别

Female

研究者

发起方

European Institute of Oncology

责任方

Sponsor

入排标准

入选标准

•Age ≥ 18 years
•WHO performance status score 0-2
•Early stage breast cancer, ER positive, receiving an adjuvant endocrine treatment with aromatase inhibitor
•Hypercholesterolemic (total cholesterol \&gt;200mg/dL)
•Ongoing treatment with aromatase inhibitors (at least six months of drug exposure)
•Adequate renal, hepatic, and hematopoietic function
•Written and informed consent for biomaterial submission and participation in the clinical trial
•Compliance with treatment and follow up protocol
•No other investigational agent may be administered concurrently to patients enrolled in this trial
•Patients with skeletal pain are eligible if bone scan and/or RX examination fails to disclose metastatic disease

排除标准

•Underweight (BMI \&lt; 18.5 kg/m2)
•Current or past eating disorders identified with the SCOFF Questionnaire (Useful Eating Disorder screening questions) \[19\]
•Malnutrition Universal Screening Tool (MUST). It considers body mass index, weight change and acute disease effect equally and determines a malnutrition risk score. A score ≥1 identify a patient at moderate risk of malnutrition;
•Treatment with any investigational or non-registered drug other than the study product(s) within 30 days preceding the first dose of study product, or planned use during the study period
•Use of statins or supplements similar to statins (e.g red rice) or other drugs that interfere with lipid absorption (e.g ezetimibe)
•Known to have difficult-to-control hypertension, coronary artery disease, arrhythmia requiring treatment, clinically significant valvular disease, cardiomegaly on chest X-ray, ventricular hypertrophy on ECG, previous myocardial infarction, or congestive heart failure Patients with diabetes are not eligible for the study
•History of allergic reactions likely to be exacerbated by any component of the investigational product used in the study
•Other concurrent, severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk
•Previous or concomitant malignancies at other sites, except effectively treated malignancy that is considered by the Investigator to have been cured
•Psychiatric or addictive disorders that may compromise the ability to give informed consent or to comply with study procedures.