Green Approach to Improved Nutritional Support for Cancer Patients
GAIN
1 other identifier
interventional
130
1 country
1
Brief Summary
In this study, we aim to reduce the burden of malnutrition in cancer patients by implementing and evaluating an improved nutritional support, using digital communication and registration tools during the clinical pathway. The project targets a group of patients with a high frequency of malnutrition, due to cancer and the subsequent therapy, where knowledge on the efficient and cost-effective treatment is scarce. The effect of the improved nutrition support will be evaluated in a randomised controlled trial, and the primary endpoint is the prevalence of malnutrition. The long-term goal is to benefit the patients by increasing the completion rate of cancer treatment, reducing the infection rate, need for antibiotics, the total length of hospital stays and number of non-elective re-admissions, and thus increasing the patients' quality of life and survival. The project will be patient-orientated and result in a sustainable approach for the management of malnutrition.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2022
CompletedFirst Posted
Study publicly available on registry
September 16, 2022
CompletedStudy Start
First participant enrolled
October 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2026
CompletedSeptember 8, 2025
April 1, 2025
3.1 years
September 8, 2022
September 1, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Malnutrition
Measured by PG-SGA
After 6 months
Secondary Outcomes (11)
Malnutrition by GLIM
6 month
Other clinical outcomes
6 months
Survival
12 months
Health-related quality of life
6 and 12 months
Cancer specific quality of life
6 and 12 months
- +6 more secondary outcomes
Study Arms (2)
Intervention
EXPERIMENTALExtra nutritional support
Control
NO INTERVENTIONUsual care
Interventions
Advice regarding energy, protein and nutrient intake during cancer treatment
Eligibility Criteria
You may qualify if:
- Adults with primary:
- gynaecologic cancer with planned radiation therapy (ca. cervix)
- colorectal cancer
- lymphomas
You may not qualify if:
- Terminal condition (life expectancy \< 6 months).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Oslo
Oslo, Oslo County, 0316, Norway
Related Publications (1)
Beichmann B, Henriksen C, Paur I, Paulsen MM. Barriers and facilitators of improved nutritional support for patients newly diagnosed with cancer: a pre-implementation study. BMC Health Serv Res. 2024 Jul 15;24(1):815. doi: 10.1186/s12913-024-11288-2.
PMID: 39010098DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christine Henriksen, PhD
University of Oslo
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate proffessor
Study Record Dates
First Submitted
September 8, 2022
First Posted
September 16, 2022
Study Start
October 1, 2022
Primary Completion
October 31, 2025
Study Completion
April 30, 2026
Last Updated
September 8, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share