Nutritional InterventionNICOSNCT06141785
Early Nutritional Intervention in Patients With Cancer
A study testing Nutritional intervention in people with Nutritional Intervention and Cancer, run by Gødstrup Hospital at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nutritional Intervention, Cancer, Malnutrition
- What is being tested?
- Nutritional intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2024to 29 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Nutritional Intervention, Cancer, Malnutrition
- Being tested
- Nutritional intervention
- Keywords
- Nutritional interventions, Dietetics, Cancer, Malnutrition, Nutrition
- Medical subject headings
- Neoplasms, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Nutritional Intervention | Experimental | Patients with Cancer treated with palliative chemotherapy. Receives: Other: Nutritional intervention |
| Historical control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Change in body weight in kilogram
Measured: baseline, week 12 (±2 weeks), week 24 (±2 weeks)
Secondary outcomes (12)
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.
Measured: baseline, week 12 (±2 weeks), week 24 (±2 weeks)
Nutritional status
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.
Measured: 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
Measured: baseline, week 12 (±2 weeks), week 24 (±2 weeks)
Survival
one-year survival will be assessed in the electronic patient journal
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: baseline, week 12 (±2 weeks), week 24 (±2 weeks)
Chemotherapy
As a measure of treatment tolerance, any change in chemotherapy drug will be registered
Measured: 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
Measured: baseline, 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
Measured: week 24 (±2 weeks)
Interruption, postponement or termination of chemotherapy
As a measure of treatment tolerance, the number of interruptions and postponements and the number of participants with termination of chemotherapy will be registered.
Measured: week 12 (±2 weeks), week 24 (±2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start1 Jun 2024
- Primary completion1 Sep 2026 (estimated)
- Study completion29 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Intervention with a historical control cohort.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gødstrup Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cancer Society
- Responsible party
- Principal investigator, Kirstine Guld Frederiksen, Gødstrup Hospital
- Investigators
- Therese Ovesen, Prof, Study director, University Clinic for Flavour, Balance and Sleep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06141785
- Sponsor's protocol ID
- KGF-1-2023
- Acronym
- NICOS
- Status last verified
- Aug 2026
- First submitted
- 7 Nov 2023
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Nutritional Intervention to Prevent Malnutrition in Patients With Cancer Receiving Palliative Chemotherapy in an Outpatient Setting
- ClinicalTrials.gov ID
- NCT06141785
- Acronym / sponsor ID
- NICOS / KGF-1-2023
- Conditions
- Nutritional Intervention, Cancer, Malnutrition
- Keywords
- Nutritional interventions, Dietetics, Cancer, Malnutrition, Nutrition
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Gødstrup HospitalUniversity, hospital or other
- Collaborators
- Danish Cancer Society
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 29 Jan 2027 (estimated)
- First posted
- 21 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention with a historical control cohort.
| Arm | Type | Receives |
|---|---|---|
| Nutritional Intervention | Experimental | Other: Nutritional interventionPatients with Cancer treated with palliative chemotherapy. |
| Historical control | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional interventionAn 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. | Other | Nutritional Intervention |
Primary outcome
Body weight
Time frame: baseline, week 12 (±2 weeks), week 24 (±2 weeks)
Change in body weight in kilogram
12 secondary outcomes
Self reported Quality of life
Time frame: baseline, week 12 (±2 weeks), week 24 (±2 weeks)
Nutritional status
Time frame: baseline, week 12 (±2 weeks), week 24 (±2 weeks)
Nutritional Risk
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)
Chemotherapy
Time frame: week 12 (±2 weeks), week 24 (±2 weeks)
Dose intensity
Time frame: baseline, week 12 (±2 weeks), week 24 (±2 weeks)
Duration of chemotherapy
Time frame: week 24 (±2 weeks)
Interruption, postponement or termination of chemotherapy
Time frame: week 12 (±2 weeks), week 24 (±2 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Nutritional Intervention
Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
Recruiting
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Excessive Gestational Weight Gain, Pregnancy
Active, not recruitingPhase 2
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Weight Loss, Gestational Diabetes Mellitus in Pregnancy
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Active, not recruiting
NYUCI-ES: Psychosocial Intervention to Improve Health Outcomes for Chinese and Korean ADRD Caregivers
Dementia Caregivers, Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Therese Ovesen, Prof study director
University Clinic for Flavour, Balance and Sleep
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional intervention in people with Nutritional Intervention and Cancer, run by Gødstrup Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: baseline, week 12 (±2 weeks), week 24 (±2 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.