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

Head and Neck Cancer Clinical Trial

— NUTREAT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05997329
• Other study ID #: 569956
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2023
• Source: University of Oslo
• Contact: Christine Henriksen, PhD
• Phone: +4799003128
• Email: christine.henriksen[@]medisin.uio.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 125
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Other:
• App for diet record (MyFood)
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.

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo
Norway	University of Oslo	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
University of Oslo	Oslo University Hospital, University of South-Eastern Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Malnutrition	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)	17 weeks
Secondary	Weight change	weight measurements	During the 17 weeks
Secondary	Nutrition intake	24-hour recall interviews	Monthly up to three months
Secondary	Body composition	Bioelectrical Impedance Analysis (BIA)	Monthly up to three months
Secondary	Health-related quality of life	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).	Monthly up to three months
Secondary	Number of Participants compliant to the intervention	Review of reported use of the MyFood app in the electronic patient record	At 17 weeks
Secondary	Number of patients with non-elective readmissions	Review of readmissions in the electronic patient record	At 17 weeks