Early Nutritional Intervention in Patients With Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGødstrup Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients not using electronic mail
patients with dementia
patients not able to comply with the study protocol
Trial design
Design model
Parallel
Treatments tested in this trial
Nutritional intervention
Other interventionAn 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
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Nutritional InterventionExperimental treatment 1 intervention
Group B: Historical controlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Body weight
Change in body weight in kilogram
Time frame
baseline, week 12 (±2 weeks), week 24 (±2 weeks)Secondary outcomes
1
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)2
Survival
one-year survival will be assessed in the electronic patient journal
Time frame
one year after initiation3
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)4
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Gødstrup Hospital
Lead sponsor
Danish Cancer Society
Collaborator
Source ClinicalTrials.gov