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Active, not recruiting

NCT Number: NCT06141785

Early Nutritional Intervention in Patients With Cancer

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Nutritional Intervention Cancer Malnutrition Neoplasms Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gødstrup Hospital

Herning, 7400, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutritional intervention

Other

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.

Primary outcomes

  1. Body weight

    Time frame: baseline, week 12 (±2 weeks), week 24 (±2 weeks)

    Change in body weight in kilogram

Secondary outcomes

  1. 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.

  2. Nutritional status

    Time frame: baseline, week 12 (±2 weeks), week 24 (±2 weeks)

    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.

  3. 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

  4. Survival

    Time frame: one year after initiation

    one-year survival will be assessed in the electronic patient journal

  5. 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

  6. 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

  7. 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.

  8. 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.

  9. 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

  10. 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

  11. 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

  12. Interruption, postponement or termination of chemotherapy

    Time frame: week 12 (±2 weeks), week 24 (±2 weeks)

    As a measure of treatment tolerance, the number of interruptions and postponements and the number of participants with termination of chemotherapy will be registered.

Sponsors and collaborators

Lead sponsor

Gødstrup Hospital

Other

Collaborators

  • Danish Cancer Society

Registry information

Official study title

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

Acronym: NICOS

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Nov 21, 2023
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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