Идёт набор NCT05968677

Effect of an Amino Acids and Flavonoids Containing FSMP on Chemotherapy Toxicity, Nutritional Status and Quality of Life in Breast Cancer Patients

Без фазы С лечением Breast Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: FSMP, Nutritional counseling.
Кому может быть актуально: Состояния в реестре: Breast Cancer. Базовые параметры: 50 лет — 70 лет · Женщины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Италия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Pragmatic, Controlled, Single-Center, Randomized Clinical Trial to Evaluate the Effect of Supplementation With an Amino Acids and Flavonoids Containing FSMP on Chemotherapy Toxicity, Nutritional Status and Quality of Life in Breast Cancer Patients

Обзор

The goal of this clinical trial is to compare the effect of a Food for Special Medical Purposes (FSMP) mainly containing amino acids and flavonoids in combination with nutritional counseling, versus nutritional counseling alone, on chemotherapy toxicity, nutritional status and quality of life in patients with breast cancer. The main questions it aims to answer are: * can this dietary supplementation affect the nutritional status of breast cancer patients? * can this dietary supplementation have any beneficial effect on chemotoxicity? Participants will be asked to undergo nutritional counseling and to take the study product every day for 12 weeks. Researchers will compare a similar group of participants only receiving the nutritional counseling to see if any difference occurs.

Подробное описание

Participants will be selected at the first oncological visit at the Outpatient Clinics or the Department of Medical Oncology of the IRCCS Policlinico San Matteo of Pavia. The doctor, evaluated the inclusion and exclusion criteria, will propose patient to participate in the study and, after obtaining informed consent, will proceed with enrollment. On the first day of chemotherapy, participants will undergo an oncological and nutritional examination, with collection of anthropometric data, assessment of body composition, assessment of quality of life through special validated questionnaires, blood sampling for blood chemistry tests and urine collection. Participants in the treated group will receive a supply of the FSMP to take home. At check-up visits, the participant's nutritional status and any adverse events will be assessed, other than adherence to treatment by delivery of empty product boxes and chemotherapy compliance. Blood chemistry tests will be repeated at 6 weeks after the first chemotherapy cycle and 3 weeks after the last chemotherapy cycle (follow-up period).

Вмешательства

Пищевая добавка FSMP
Food for Special Medical Purposes specifically formulated for the dietary management of malnourished patients following therapeutic treatments such as chemo and radiotherapy
Другое Nutritional counseling
Participant's nutritional status will be evaluated, anthropometric data will be collected (weight, height, BMI), body composition will be evaluated (FFMI, BIVA) and a food diary will be compiled

Первичные конечные точки

Mean change from baseline in High-Sensitivity Troponin Levels as a serological marker of chemotherapy cardiotoxicity [Срок оценки: 0, 6, 12 weeks]

Вторичные конечные точки (8)

Mean change from baseline in weight, Body Mass Index (BMI) and Fat Free Mass Index (FFMI) [Срок оценки: 0, 3, 6, 9, 12 weeks]
Mean change from baseline in Phase Angle [Срок оценки: 0, 3, 6, 9, 12 weeks]
Mean change from baseline in Bioelectrical Impedance Vector Analysis (BIVA) [Срок оценки: 0, 3, 6, 9, 12 weeks]
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [Срок оценки: 3, 6, 9, 12 weeks]
Mean change from baseline in Interleukine-6 levels [Срок оценки: 0, 6, 12 weeks]
Mean change from baseline Interleukine-1 beta levels [Срок оценки: 0, 6, 12 weeks]
Mean change from baseline in C-reactive Protein levels [Срок оценки: 0, 6, 12 weeks]
Participant's perception of her physical and mental state [Срок оценки: 0, 12 weeks]

Критерии участия

Критерии включения

Diagnosis of non-metastatic ductal breast cancer
Post-menopausal women
Chemotherapy with Doxorubicin or Epirubicin, with or without Cyclophosphamide, scheduled as adjuvant or neo-adjuvant
Written informed consent
Independent oral feeding
Must be able to carry out periodic visits