Early Nutritional Intervention in Patients With Cancer (NICOS)

December 17, 2025 updated by: Kirstine Guld Frederiksen, Gødstrup Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kirstine Guld Frederiksen, MSc
  • Phone Number: 45 24248914
  • Email: kirsfe@rm.dk

Study Locations

  • Denmark
      • Herning, Denmark, 7400
        • Recruiting
        • Gødstrup Hospital
        • Principal Investigator:
          • Therese Ovesen, Prof
        • Contact:
          • Kirstine Guld Frederiksen, MSc
          • Phone Number: 45 24248914
          • Email: kirsfe@rm.dk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nutritional Intervention
Patients with Cancer treated with palliative chemotherapy.
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
No Intervention: Historical control

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
Time Frame: baseline, week 12 (±2 weeks), week 24 (±2 weeks)
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
Time Frame: baseline, week 12 (±2 weeks), week 24 (±2 weeks)
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
Time Frame: one year after initiation
one-year survival will be assessed in the electronic patient journal
one year after initiation
Muscle mass
Time Frame: baseline and week 24 (±2 weeks)
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
Time Frame: baseline, week 12 (±2 weeks), week 24 (±2 weeks)
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
Time Frame: baseline, week 12 (±2 weeks), week 24 (±2 weeks)
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
Time Frame: baseline, week 12 (±2 weeks), week 24 (±2 weeks)
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
Time Frame: baseline, week 12 (±2 weeks), week 24 (±2 weeks)
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
Time Frame: baseline, week 12 (±2 weeks), week 24 (±2 weeks)
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
Time Frame: week 12 (±2 weeks), week 24 (±2 weeks)
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
Time Frame: week 24 (±2 weeks)
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
Time Frame: week 12 (±2 weeks), week 24 (±2 weeks)
As a measure of treatment tolerance, the number of postponements of chemotherapy will be registered.
week 12 (±2 weeks), week 24 (±2 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gødstrup Hospital

Collaborators

Danish Cancer Society

Investigators

  • Study Director: Therese Ovesen, Prof, University Clinic for Flavour, Balance and Sleep

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

January 29, 2027

Study Registration Dates

First Submitted

November 7, 2023

First Submitted That Met QC Criteria

November 17, 2023

First Posted (Actual)

November 21, 2023

Study Record Updates

Last Update Posted (Actual)

December 24, 2025

Last Update Submitted That Met QC Criteria

December 17, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KGF-1-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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