NCT05997329

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
125

participants targeted

Target at P75+ for not_applicable head-and-neck-cancer

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 18, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

September 8, 2025

Status Verified

August 1, 2025

Enrollment Period

2 years

First QC Date

June 26, 2023

Last Update Submit

September 1, 2025

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

  • Malnutrition_PGSGA

    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)

    18 weeks

Secondary Outcomes (7)

  • Malnutrition GLIM

    18 weeks

  • Weight change

    18 weeks

  • Nutrition intake

    18 weeks

  • Body composition

    18 weeks

  • Health-related quality of life

    18 weeks

  • +2 more secondary outcomes

Study Arms (2)

MyFood (App for diet record)

EXPERIMENTAL

Use of an App for diet record

Other: App for diet record (MyFood)

Usual care

NO INTERVENTION

Usual care

Interventions

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.

MyFood (App for diet record)

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Head and neck cancer
  • Older than 18 years

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Oslo

Oslo, Oslo County, 0316, Norway

Location

Oslo University Hospital

Oslo, Norway

Location

Related Publications (1)

  • Severinsen F, Varsi C, Andersen LF, Henriksen C, Paulsen MM. Experiences with nutritional follow-up and barriers and opportunities of implementing digital seamless nutrition care in the head and neck cancer treatment course: a qualitative study from patient, family caregiver, and healthcare professional perspectives. BMC Health Serv Res. 2025 Oct 14;25(1):1358. doi: 10.1186/s12913-025-13542-7.

    PMID: 41088125DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

AmyloidDiet Records

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Multiprotein ComplexesMacromolecular SubstancesProteinsAmino Acids, Peptides, and ProteinsRecordsOrganization and AdministrationHealth Services Administration

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

June 26, 2023

First Posted

August 18, 2023

Study Start

November 1, 2023

Primary Completion

October 30, 2025

Study Completion

October 31, 2025

Last Updated

September 8, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

NO(2)