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

Not Applicable

Active, not recruiting

• Conditions: Head and Neck Cancer

• Registration Number: NCT05997329
• Lead Sponsor: University of Oslo

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-26
• Study First Submitted QC: 2023-08-09
• Study First Posted: 2023-08-18
• Study Start: 2023-11-01
• Status Verified: 2025-08
• Last Update Submitted: 2025-09-01
• Last Update Posted: 2025-09-08
• Primary Completion: 2025-10-30
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 125

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Malnutrition_PGSGA	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 Outcome Measures

Name	Time	Method
Malnutrition GLIM	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.
Nutrition intake	18 weeks	24-hour recall interviews
Health-related quality of life	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).
Number of Participants compliant to the intervention	18 weeks	Review of reported use of the MyFood app in the electronic patient record
Number of patients with non-elective readmissions	18 weeks	Review of readmissions in the electronic patient record
Weight change	18 weeks	weight measurements
Body composition	18 weeks	Bioelectrical Impedance Analysis (BIA)

Trial Locations

Locations (2)

University of Oslo; 🇳🇴 Oslo, Oslo County, Norway

Oslo University Hospital; 🇳🇴 Oslo, Norway