Fasting-mimicking Diet Intervention on Side Effects of Aromatase Inhibitors Treatment in Patients With Breast Cancer

Официальное название

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

Обзор

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.

Подробное описание

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

Вмешательства

• Пищевая добавка FASTING-MIMICKING DIET PROGRAM
  Nutritional intervention via fasting-mimicking diet. Patients receiving adjuvant therapy with aromatase inhibitors will be randomized 1:1 into two arms: one intervention, where will receive nutritional counseling and the study diet for 5 days each month for 6 months,and a control one, where they will receive only nutritional counseling.

Первичные конечные точки

• Fasting-mimicking diet [Срок оценки: from baseline to the end of treatment at 12 month]

Критерии участия

Критерии включения

• 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 \>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
• The interval between the onset of systemic adjuvant therapy with AIs and the randomization should be at least 6 months
• Patient is accessible geographically for follow-up and must be able to provide dietary data via telephone recalls
• Must be medically able to accept either dietary supplementation group prior to randomization.

Критерии исключения

• Underweight (BMI \< 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Италия · 1 центр

• IEO — Milan

Идентификаторы

NCT: NCT06610565 · IEO 1570

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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