Early Nutritional Intervention in Patients With Cancer (NICOS)
Early Nutritional Intervention to Prevent Malnutrition in Patients With Cancer Receiving Palliative Chemotherapy in an Outpatient Setting
Study Overview
Status
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Herning, Denmark, 7400
- Gødstrup Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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 able to read, write and speak Danish
- patients ≥18 years of age
- patients who are cognitive well-functioning
Exclusion Criteria:
- Significant cognitive impairment (e.g. dementia) compromising the ability to provide informed consent or participate meaningfully in the intervention
- Lack of access to electronic mail
- Inability to comply with the study protocol due to medical, psychosocial or practical factors
Study Plan
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 |
|---|---|
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Experimental: Nutritional Intervention
Patients with Cancer treated with palliative chemotherapy.
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An individualised nutritional intervention delivered by a clinical dietitian from initiation of palliative chemotherapy and throughout the 24-week study period.
The intervention is tailored to each participant's nutritional requirements, nutritional status, food preferences, nutrition impact symptoms, and smell and taste alterations.
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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 |
|---|---|---|
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Body weight
Time Frame: baseline, week 12 (±2 weeks), week 24 (±2 weeks)
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Change in body weight in kilogram
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baseline, week 12 (±2 weeks), week 24 (±2 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Self reported Quality of life
Time Frame: baseline, week 12 (±2 weeks), week 24 (±2 weeks)
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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.
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baseline, week 12 (±2 weeks), week 24 (±2 weeks)
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Survival
Time Frame: one year after initiation
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one-year survival will be assessed in the electronic patient journal
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one year after initiation
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Muscle mass
Time Frame: baseline and week 24 (±2 weeks)
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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
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baseline and week 24 (±2 weeks)
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Performance status
Time Frame: baseline, week 12 (±2 weeks), week 24 (±2 weeks)
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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
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baseline, week 12 (±2 weeks), week 24 (±2 weeks)
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Hand grip strength
Time Frame: baseline, week 12 (±2 weeks), week 24 (±2 weeks)
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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.
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baseline, week 12 (±2 weeks), week 24 (±2 weeks)
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Timed up and go
Time Frame: baseline, week 12 (±2 weeks), week 24 (±2 weeks)
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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.
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baseline, week 12 (±2 weeks), week 24 (±2 weeks)
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Nutritional Risk
Time Frame: baseline, week 12 (±2 weeks), week 24 (±2 weeks)
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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
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baseline, week 12 (±2 weeks), week 24 (±2 weeks)
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Dose intensity
Time Frame: baseline, week 12 (±2 weeks), week 24 (±2 weeks)
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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
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baseline, week 12 (±2 weeks), week 24 (±2 weeks)
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Chemotherapy
Time Frame: week 12 (±2 weeks), week 24 (±2 weeks)
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As a measure of treatment tolerance, any change in chemotherapy drug will be registered
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week 12 (±2 weeks), week 24 (±2 weeks)
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Duration of chemotherapy
Time Frame: week 24 (±2 weeks)
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As a measure of treatment tolerance, the duration of treatment with chemotherapy will be registered in days
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week 24 (±2 weeks)
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Nutritional status
Time Frame: baseline, week 12 (±2 weeks), week 24 (±2 weeks)
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Nutritional status will be assessed using the Patient-Generated Subjective Global Assessment Short Form (PG-SGA SF), which evaluates weight history, food intake, nutrition impact symptoms, and activity and function.
Total scores range from 0 to 36, with higher scores indicating poorer nutritional status and a greater need for nutritional intervention.
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baseline, week 12 (±2 weeks), week 24 (±2 weeks)
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Interruption, postponement or termination of chemotherapy
Time Frame: week 12 (±2 weeks), week 24 (±2 weeks)
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As a measure of treatment tolerance, the number of interruptions and postponements and the number of participants with termination of chemotherapy will be registered.
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week 12 (±2 weeks), week 24 (±2 weeks)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Therese Ovesen, Prof, University Clinic for Flavour, Balance and Sleep
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KGF-1-2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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