Идёт набор NCT06141785

Early Nutritional Intervention in Patients With Cancer

Без фазы С лечением Nutritional Intervention Cancer Malnutrition

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: Nutritional intervention.
Кому может быть актуально: Состояния в реестре: Nutritional Intervention, Cancer, Malnutrition. 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: Дания
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

Early Nutritional Intervention to Prevent Malnutrition in Patients With Cancer Receiving Palliative Chemotherapy in an Outpatient Setting

Обзор

The goal of this intervention study is to study the effect of nutritional interventions in patients with cancer receiving palliative chemotherapy. The main question it aims to answer is: Does early nutritional interventions affect body weight, quality of life, survival, muscle mass, performance status, physical function, nutritional risk and treatment tolerance in patients with cancer receiving palliative chemotherapy? Researchers will compare patients receiving the intervention to a historical control cohort following current clinical practice.

Подробное описание

Background 30-50% of patients with cancer are malnourished, resulting in poorer prognosis, increased toxicities, reduced quality of life, and reduced physical function. Nevertheless, cancer-related malnutrition remains largely unrecognized and undertreated in clinical practice.

Aim To examine the effect of an early individualised nutritional intervention on body weight, quality of life, survival, muscle mass, performance status, physical function, nutritional risk, and treatment tolerance in patients with cancer receiving palliative chemotherapy.

Methods An intervention study with a historical control cohort. Participants are newly diagnosed patients with lung, pancreatic, ovarian, or colorectal cancers recruited at initiation of palliative chemotherapy. The control group followed current clinical practice. The intervention group receives an individualised nutritional intervention delivered by a clinical dietitian from treatment initiation and throughout the treatment trajectory. The intervention is tailored to the participant's nutritional needs, food preferences, nutrition impact symptoms, and smell- and taste disorders. The primary endpoint is change in body weight. Secondary endpoints include quality of life, survival, muscle mass, performance status, physical function, nutritional risk, and treatment tolerance. Data are collected at baseline and after 12 and 24 weeks.

Perspectives The project will provide new knowledge on the effects of individualised nutritional interventions for patients with cancer receiving palliative chemotherapy, and the potential to improve quality of life, treatment tolerance, and survival.

Вмешательства

Другое Nutritional intervention
An individually targeted nutritional intervention, and a simple home-based physical exercise program. The Nutritional intervention will be delivered by a clinical dietitian, from treatment initiation and throughout the treatment trajectory

Первичные конечные точки

Body weight [Срок оценки: baseline, week 12 (±2 weeks), week 24 (±2 weeks)]

Вторичные конечные точки (11)

Self reported Quality of life [Срок оценки: baseline, week 12 (±2 weeks), week 24 (±2 weeks)]
Survival [Срок оценки: one year after initiation]
Muscle mass [Срок оценки: baseline and week 24 (±2 weeks)]
Performance status [Срок оценки: baseline, week 12 (±2 weeks), week 24 (±2 weeks)]
Hand grip strength [Срок оценки: baseline, week 12 (±2 weeks), week 24 (±2 weeks)]
Timed up and go [Срок оценки: baseline, week 12 (±2 weeks), week 24 (±2 weeks)]
Nutritional Risk [Срок оценки: baseline, week 12 (±2 weeks), week 24 (±2 weeks)]
Dose intensity [Срок оценки: baseline, week 12 (±2 weeks), week 24 (±2 weeks)]
Chemotherapy [Срок оценки: week 12 (±2 weeks), week 24 (±2 weeks)]
Duration of chemotherapy [Срок оценки: week 24 (±2 weeks)]
Postponements in chemotherapy treatment [Срок оценки: week 12 (±2 weeks), week 24 (±2 weeks)]

Критерии участия

Критерии включения

patients who are newly diagnosed with lung, colorectal, ovarian, or pancreatic cancer.
patients treated with first-line palliative chemotherapy
patients who are Danish speaking
patients ≥18 years of age
patients who are cognitive well-functioning