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Идёт набор NCT06480266

Influence of Protein Intake on Muscle Mass and Health-related Quality of Life During and After Radiotherapy

Наблюдательное Malnutrition; Cachexia

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Malnutrition; Cachexia. Базовые параметры: 45 лет — 75 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
Германия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Influence of Protein Intake on Muscle Mass and Health-related Quality of Life During and After Radiotherapy in Patients With Various Tumor Diseases

Обзор

The influence of radiotherapy on the protein intake and muscle mass of patients has not been extensively investigated to date. It is also unclear whether the localization of the tumor disease and thus the radiation field have different effects. Therefore, with the pilot study presented here, we would like to record the nutritional uptake of patients before and after radiotherapy. The aim is to determine the amount of energy and protein intake as well as the timing of protein intake. Furthermore, the relationship between the timing of protein intake and muscle mass will be investigated.

Подробное описание

Many studies have shown that cancer patients have a very high prevalence of malnutrition. Several large-scale studies have reported that 50-80% of these patients are affected by involuntary weight loss, with the extent of weight loss depending on the tumor location and the type and stage of the disease. It has been widely reported that nutritional interventions are essential in cancer patients. Nevertheless, nutritional support is still not universally accessible to all patients. Given the prevalence of nutritional risks, the treatment of lean muscle mass loss remains a challenge in clinical practice. For this reason, a multidisciplinary approach with targeted nutritional therapy is crucial to improve the quality of care in oncology. A protein level of 1-1.2 g/kg bw is suggested for the maintenance of muscle mass.However, it has been shown that this amount is not sufficient to support ALM in patients with tumor diseases. Only an amount above 1.4 g/kg bw has been associated with a positive effect on muscle mass. Adequate dietary protein intake is essential for the maintenance of numerous physiological processes, including muscle protein synthesis and muscle function. Sufficient energy and protein intake is necessary to support muscle protein synthesis. The scientific literature frequently discusses the relationship between daily protein intake and its distribution over the main meals. The evening meal is particularly important for the maintenance of ALM.

Первичные конечные точки

  • Protein uptake in g/kg body weight [Срок оценки: baseline, end of radiotherapy and 3 months after Radiotherapy]
Вторичные конечные точки (8)
  • Weight in kg [Срок оценки: baseline, end of radiotherapy and 3 months after Radiotherapy]
  • Muscle mass in kg [Срок оценки: baseline, end of radiotherapy and 3 months after Radiotherapy]
  • Quality of Life (EORTC QLQ C30) in 5-tier likert scale (higher scores = better) [Срок оценки: baseline, end of radiotherapy and 3 months after Radiotherapy]
  • Height in m [Срок оценки: baseline, end of radiotherapy and 3 months after Radiotherapy]
  • Fatigue in 5-tier likert scale (higher scores = worse) [Срок оценки: baseline, end of radiotherapy and 3 months after Radiotherapy]
  • BMI in kg/m² [Срок оценки: baseline, end of radiotherapy and 3 months after Radiotherapy]
  • Treatment Toxicity via CTCA criteria (5 tier scale; higher = worse) [Срок оценки: baseline, weekly during radiotherapy, end of treatment, follow up (up to 1 year, on average every 3 months)]
  • Treatment Toxicity via PROMs (5 tier scale; higher = worse) [Срок оценки: baseline, weekly during radiotherapy, end of treatment, follow up (up to 1 year, on average every 3 months)]

Критерии участия

Критерии включения

  • Capacity to consent
  • At least 45 years of age
  • Sufficient knowledge of the German language
  • Indication to undergo radio(chemo)therapy with at least 10 fractions

Критерии исключения

  • Participation in other interventional studies
  • Pregnancy/breastfeeding
  • Previous intake of high-calorie supplementary food or intravenous nutrition
  • BMI < 18.5
  • When performing the bioimpedance measurement: patients with pacemakers, defibrillators and other implanted automatic devices

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

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Германия · 1 центр
  • Charité University Medicine Berlin — Berlin

Идентификаторы

NCT: NCT06480266 · EA1/101/23

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗