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Clinical Trials/NCT05997329
NCT05997329
Active, not recruiting
Not Applicable

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

University of Oslo2 sites in 1 country125 target enrollmentNovember 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Head and Neck Cancer
Sponsor
University of Oslo
Enrollment
125
Locations
2
Primary Endpoint
Malnutrition_PGSGA
Status
Active, not recruiting
Last Updated
7 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2023
End Date
October 31, 2025
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Christine Henriksen

Associate professor

University of Oslo

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

  • Malnutrition GLIM(18 weeks)
  • Nutrition intake(18 weeks)
  • Health-related quality of life(18 weeks)
  • Number of Participants compliant to the intervention(18 weeks)
  • Number of patients with non-elective readmissions(18 weeks)
  • Weight change(18 weeks)
  • Body composition(18 weeks)

Study Sites (2)

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