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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
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
Gødstrup Hospital
Herning, Denmark
RECRUITINGBody weight
Change in body weight in kilogram
Time frame: baseline, week 12 (±2 weeks), week 24 (±2 weeks)
Self reported Quality of life
Measured by the questionnaire European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group (QLG) Core Questionnaire: Quality of Life (QLQ) Core 30 (EORTC QLQ-C30) using a Likert scale ranging from 1 to 4 for questions regarding function and symptoms, where a high score corresponds to a worse outcome, and a Likert scale ranging from 1 to 7 for questions regarding Global Health Status and Quality of Life, where a high score corresponds to a better outcome.
Time frame: baseline, week 12 (±2 weeks), week 24 (±2 weeks)
Survival
one-year survival will be assessed in the electronic patient journal
Time frame: one year after initiation
Muscle mass
CT scans to measure paraspinal muscle mass at the level of lumbal spine 3 (L3) which will also be assessed using measurements from the bio impedance scale
Time frame: baseline and week 24 (±2 weeks)
Performance status
Patient's performance status will be assessed by the treating physician according to the Eastern Cooperative Oncology Group (ECOG) classification on a scale ranging from 0 to 5, where a high score corresponds to a worse outcome
Time frame: baseline, week 12 (±2 weeks), week 24 (±2 weeks)
Hand grip strength
The Hand grip strength as a measure of physical function will be estimated. Hand grip strength will be measured using a hand dynamometer ("CAMRY" Digital Hand Dynamometer). The hand grip strength will be measured three times in the dominant hand, and the highest value in kilogram is registered.
Time frame: baseline, week 12 (±2 weeks), week 24 (±2 weeks)
Timed up and go
Timed up and go, as a measure om physical function, will be performed in the hallway from a chair with armrest. The patient is asked to walk three meters to a marked spot on the floor, return and sit down as quickly as possible without running. The test is performed twice, and the quickest time measurement is registered. The result is registered in seconds.
Time frame: baseline, week 12 (±2 weeks), week 24 (±2 weeks)
Nutritional Risk
To assess the nutritional risk, the patient will be screened by Nutrition Risk Screening 2002 (NRS-2002). This tool calculates a score based on information about Body Mass Index, weight loss, nutritional intake, severity of disease, and age. Results can be between 0 and 7, where a high score corresponds to a worse outcome
Time frame: baseline, week 12 (±2 weeks), week 24 (±2 weeks)
Dose intensity
As a measure of treatment tolerance, dose intensity is registered on a scale ranging from 0 to -2, where 0 corresponds to a better outcome
Time frame: baseline, week 12 (±2 weeks), week 24 (±2 weeks)
Chemotherapy
As a measure of treatment tolerance, any change in chemotherapy drug will be registered
Time frame: week 12 (±2 weeks), week 24 (±2 weeks)
Duration of chemotherapy
As a measure of treatment tolerance, the duration of treatment with chemotherapy will be registered in days
Time frame: week 24 (±2 weeks)
Postponements in chemotherapy treatment
As a measure of treatment tolerance, the number of postponements of chemotherapy will be registered.
Time frame: week 12 (±2 weeks), week 24 (±2 weeks)
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