Early Nutritional Intervention in Patients With Cancer

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Nutritional Intervention, Cancer, Malnutrition

Intervention / Treatment
-----------------
* Other: Nutritional intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: Patients not using electronic mail patients with dementia patients not able to comply with the study protocol

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intervention with a historical control cohort.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutritional Intervention<br>Patients with Cancer treated with palliative chemotherapy. | Other: Nutritional intervention<br>* 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<br>|
| No Intervention: Historical control<br>Patients with Cancer treated with palliative chemotherapy. Historical Control cohort following current clinical practise, where nutritional treatment is not systematically implemented but patients can be referred to a clinical dietitian after clinical assessment by the treating physician or nurse. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight | Change in body weight in kilogram | baseline, week 12 (±2 weeks), week 24 (±2 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline, week 12 (±2 weeks), week 24 (±2 weeks) | 
| Survival | one-year survival will be assessed in the electronic patient journal | 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 | 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 | 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. | 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. | 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 | 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 | baseline, week 12 (±2 weeks), week 24 (±2 weeks) | 
| Chemotherapy | As a measure of treatment tolerance, any change in chemotherapy drug will be registered | 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 | week 24 (±2 weeks) | 
| Postponements in chemotherapy treatment | As a measure of treatment tolerance, the number of postponements of chemotherapy will be registered. | week 12 (±2 weeks), week 24 (±2 weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nutritional interventions, Dietetics, Cancer, Malnutrition, Nutrition