Early Nutritional Intervention in Patients With Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nutritional intervention.
- Who it may be relevant to
- Registry conditions: Nutritional Intervention, Cancer, Malnutrition. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Early Nutritional Intervention to Prevent Malnutrition in Patients With Cancer Receiving Palliative Chemotherapy in an Outpatient Setting
Overview
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.
Interventions
- Other 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
Primary outcome measures
- Body weight [Time frame: baseline, week 12 (±2 weeks), week 24 (±2 weeks)]
Secondary outcome measures (11)
- Self reported Quality of life [Time frame: baseline, week 12 (±2 weeks), week 24 (±2 weeks)]
- Survival [Time frame: one year after initiation]
- Muscle mass [Time frame: baseline and week 24 (±2 weeks)]
- Performance status [Time frame: baseline, week 12 (±2 weeks), week 24 (±2 weeks)]
- Hand grip strength [Time frame: baseline, week 12 (±2 weeks), week 24 (±2 weeks)]
- Timed up and go [Time frame: baseline, week 12 (±2 weeks), week 24 (±2 weeks)]
- Nutritional Risk [Time frame: baseline, week 12 (±2 weeks), week 24 (±2 weeks)]
- Dose intensity [Time frame: baseline, week 12 (±2 weeks), week 24 (±2 weeks)]
- Chemotherapy [Time frame: week 12 (±2 weeks), week 24 (±2 weeks)]
- Duration of chemotherapy [Time frame: week 24 (±2 weeks)]
- Postponements in chemotherapy treatment [Time frame: week 12 (±2 weeks), week 24 (±2 weeks)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Gødstrup Hospital — Herning
Identifiers
NCT: NCT06141785 · KGF-1-2023