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Active, Not Recruiting

NCT Number: NCT05997329

Nutrition Throughout the Treatment Course - Expanding Care From Hospital to Home

Patients with cancer have increased risk of malnutrition due to the disease itself and the treatment regimen they undergo. This is particularly relevant for patients with head and neck cancer (HNC), where 74%-95% are malnourished. HNC is a heterogenous group of cancers, including oral cavity, larynx, pharynx and salivary glands. The present project will study the effectiveness and implementation of remote patient monitoring of nutrition and tailored nutrition support throughout the treatment course in patients with head and neck cancer. The implementation will be evaluated in a randomized controlled trial (RCT), and the aim of the project is to reduce the prevalence of malnutrition and increase the quality of life among patients with HNC.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oslo, Oslo, Norway

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Head and neck cancer
  • Older than 18 years

Exclusion criteria

  • Patients admitted with the classification of malignant tumors (TNM) stage 4
  • Terminal condition (life expectancy < 6 months)
  • Patients who do not understand the Norwegian language.

Treatment and study plan

App for diet record (MyFood)

Other

Patients in the intervention group will record their food intake, tube feeding, nutrition-related symptoms and body weight in the MyFood app in at least three consecutive days in advance of follow-up.The patients will thus be able to keep track of their nutrition status. They will also have access to nutrition tips for how to reach requirements if they struggle to eat sufficiently or relief symptoms that can affect food intake.Healthcare staff at the hospital and outpatient clinics will use MyFood to monitor the patient's nutrition and document this information in the electronic patient record. They will also receive decision support tailored to each individual patient, e.g. recommendations for how to use oral nutrition supplements if the patient's intake of energy or protein is too low. Patients who struggle to fulfill their requirements will receive an additional referral to a registered dietitian for nutrition treatment between week 5 and 11.

Primary outcomes

  1. Malnutrition_PGSGA

    Time frame: 18 weeks

    Measured by the: Patient-Generated Subjective Global Assessment (PG-SGA). The tool categories participants into: category A (Well-nourished), B (Moderately malnutrition or possible malnutrition), or C (serious malnutrition)

Secondary outcomes

  1. Malnutrition GLIM

    Time frame: 18 weeks

    Malnutrition measured by the objective method developed by the Global Leadership Initiative on Malnutrition (GLIM). The GLIM-criteria also categories the participants i three groups: Well-nourished, moderate malnutrition and severe malnutrition.

  2. Weight change

    Time frame: 18 weeks

    weight measurements

  3. Nutrition intake

    Time frame: 18 weeks

    24-hour recall interviews

  4. Body composition

    Time frame: 18 weeks

    Bioelectrical Impedance Analysis (BIA)

  5. Health-related quality of life

    Time frame: 18 weeks

    EuroQol Research Foundation, Netherlands (EQ5D-5L). Assess health in 5 dimensions each of which has three response levels (1: No problems, 2: some problems and 3: extreme problems/unable to do).

  6. Number of Participants compliant to the intervention

    Time frame: 18 weeks

    Review of reported use of the MyFood app in the electronic patient record

  7. Number of patients with non-elective readmissions

    Time frame: 18 weeks

    Review of readmissions in the electronic patient record

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Collaborators

  • Oslo University Hospital
  • University of South-Eastern Norway

Registry information

Acronym: NUTREAT

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 18, 2023
Registry last updated
Sep 8, 2025

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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