Impact of Specific Oligomeric Supplementation in Oncologic Patients Undergoing Radiotherapy With Malnutrition or at Risk.
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Oral supplementation with nutritional oligomeric formula.
- Кому может быть актуально
- Состояния в реестре: Malnutrition in Elderly, Oncological Patients, Digestive Disorders. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Испания
- 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
Effects of the Specific Supplementation (100% Seric Hydrolized Lactoprotein and MCT) in Malnourished Oncologic Patients Undergoing Radiotherapy
Обзор
An observational, prospective, multicenter study to be conducted in 5 hospitals in Spain. Patients with cancer undergoing radiotherapy are malnourished or at risk of malnutrition. Due to the characteristics of their pathology or gastrointestinal disorders, the use of oligomeric nutritional formulas formulated with 100% hydrolyzed whey lactoprotein and a high MCT content is recommended as part of routine clinical practice. Patients will be followed for 12 weeks, with three visits: a baseline visit upon inclusion in the study, after 6 weeks and a final visit 12 weeks after the nutritional treatment starts.
Подробное описание
The prevalence of malnutrition is high in cancer patients: about 80% of patients will suffer from malnutrition at some point, and it is the cause of 10-20% of deaths in this type of patient.
To address malnutrition in these patients, international clinical guidelines recommend periodically reviewing their nutritional status and supplementing with oral nutrition formulas (ONS) when they are unable to meet their nutritional needs from their usual diet.
The ONSs have a nutrient composition designed to meet the specific needs of the patient, but there are pathologies, types of tumours and treatments, such as radiotherapy, chemotherapy, immunotherapy and others that can alter the digestion process, making it difficult for the gastrointestinal tract to utilise nutrients. Patients with these pathologies often cannot tolerate polymeric SNO formulations and require oligomeric peptide-based diet (PBD) formulations.
PBDs contain hydrolysed proteins in the form of peptides and medium-chain triglycerides (MCTs), which are more easily assimilated, helping patients to reduce weight loss and improve overall nutritional status. In addition, they contain hydrolysed serum lactoprotein with high biological quality that stimulates the formation of muscle tissue, minimising cachexia.
Radio/chemotherapy/immunotherapy treatment has negative effects on the nutritional and functional status of cancer patients, which also makes them more susceptible to the toxicities of cancer treatments and clinical complications. It has been shown that these patients tolerate PBD formulas well and even reduce their baseline intestinal symptoms, which facilitates compliance with nutritional treatment. However, adherence to these treatments remains a challenge as it is not always optimal, resulting in the non-achievement of the potential benefits.
The main objective of the study is to evaluate the effects of a hypercaloric SNO, with 100% hydrolysed serum lactoprotein and high MCT intake, in cancer patients undergoing radiotherapy, malnourished or at risk of malnutrition, in terms of improving the patient's nutritional status after 12 weeks of treatment.
Вмешательства
- Пищевая добавка Oral supplementation with nutritional oligomeric formula
Patients will be supplemented with the specific oligomeric formula (1 or 2 bottles/day, as per investigator's decision) during, at least, the 12 weeks of the study follow-up.
Первичные конечные точки
- Percentage of patients who improve the degree of malnutrition. [Срок оценки: From enrollment to the end of treatment at 12 weeks]
Вторичные конечные точки (12)
- Percentage of patients with improvement in the degree of malnutrition [Срок оценки: From enrollment to the end of treatment at 12 weeks]
- Percentage change in BMI [Срок оценки: From enrollment to the end of treatment at 12 weeks]
- Arm circumference [Срок оценки: From enrollment to the end of treatment at 12 weeks]
- Calf circumference [Срок оценки: From enrollment to the end of treatment at 12 weeks]
- Maximum prehensile strength value [Срок оценки: From enrollment to the end of treatment at 12 weeks]
- Sit-to-stand test [Срок оценки: From enrollment to the end of treatment at 12 weeks]
- Impedancemetry values [Срок оценки: From enrollment to the end of treatment at 12 weeks]
- Percentage of patients presenting complications associated with nutritional status during treatment. [Срок оценки: From enrollment to the end of treatment at 12 weeks]
- Percentage of patients presenting changes in gastrointestinal tolerance after 6 and after 12 weeks of treatment with SNO with 100% hydrolyzed serum [Срок оценки: After 6 and after 12 weeks of treatment]
- Distribution of the patients according to their compliance with the treatment [Срок оценки: At 6 and 12 weeks of treatment.]
- Distribution of the patients according to their adherence to the treatment [Срок оценки: At 6 and 12 weeks of treatment.]
- Percentage of patients who maintain or improve their quality of life after 12 weeks of treatment. [Срок оценки: After 12 weeks of treatment.]
Критерии участия
Критерии включения
- Patients of legal age (≥18 years).
- Oncology patients (with head and neck, lung or rectal cancer) undergoing or about to start radiotherapy treatment. Patients with oesophageal cancer will also be included, as long as the patient is not undergoing PEG.
- Patients who are malnourished or at risk of malnutrition according to GLIM criteria.
- Patients requiring supplementation with an oligomeric formula with 100% hydrolysed serum lactoprotein and high MCT intake due to gastrointestinal disturbances (either maldigestion or maldigestion, malabsorption or dysmotility) intolerance to polymeric formulations or any other reason as considered by the physician.
- Patients who, at the discretion of the investigator, have the ability to answer the questionnaires and follow the procedures detailed in the protocol.
- Patients who give written informed consent to participate.
Критерии исключения
- Patients with galactosemia, allergies and/or intolerances to lactose or any of the compounds of the formula.
- Patients receiving nutritional support other than that of the study characteristics or who have received it during the last month. It will be accepted in patients who, being on a polymeric SNO, are advised to change to the oligomeric formula under study, due to gastrointestinal alterations, intolerances or any other reason considered by the doctor.
- Patients who have undergone surgery in the last three months.
- Patients who have received Enteral Nutrition in the last 3 months for SNG/SNJ/PEG.
- Pregnant or lactating women.
- Patients with advanced renal or hepatic disease (with creatinine clearance less than 45 ml/min or CP=C).
- Patients with advanced neoplastic disease with life expectancy <3 months.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Испания · 4 центра
- Hospital Universitario San Juan de Alicante — Alicante
- Hospital Universitario Fundación Jiménez Díaz — Madrid
- HU Clinica Asturias — Oviedo
- Hospital Universitario Son Espases — Palma de Mallorca
Идентификаторы
NCT: NCT07035132 · NES-2023-154-PRO-PEP