Actively Recruiting
Early Nutritional Intervention to Prevent Malnutrition in Patients With Cancer Receiving Palliative Chemotherapy in an Outpatient Setting
Led by Gødstrup Hospital · Updated on 2025-12-24
200
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
Sponsors
G
Gødstrup Hospital
Lead Sponsor
D
Danish Cancer Society
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to study the effects of early nutritional interventions on patients with cancer who are receiving palliative chemotherapy. It focuses on whether these interventions impact body weight, quality of life, survival, muscle mass, physical function, nutritional risk, and treatment tolerance. The study compares patients receiving the nutritional intervention to a historical control group following current clinical practice. Participants newly diagnosed with lung, pancreatic, ovarian, or colorectal cancer start first-line palliative chemotherapy and receive an individualized nutritional intervention from a clinical dietitian. This intervention is tailored to each patient's nutritional needs, food preferences, and symptoms affecting taste and smell. The study also includes a simple home-based physical exercise program. The intervention is delivered from the start of treatment and continues throughout the chemotherapy period. The control group receives standard care without systematic nutritional treatment but may be referred to a dietitian after clinical assessment. Participants are assessed at baseline, 12 weeks, and 24 weeks for body weight, quality of life, muscle mass, performance status, hand grip strength, timed up and go test, nutritional risk, chemotherapy dose intensity, treatment postponements, and survival up to one year. Data collection includes self-reported questionnaires and clinical measurements to monitor treatment tolerance and physical function. The study aims to provide insights into how early nutritional support may improve the overall experience and outcomes for cancer patients undergoing palliative chemotherapy.
CONDITIONS
Brief Title
Early Nutritional Intervention in Patients With Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who are newly diagnosed with lung, colorectal, ovarian, or pancreatic cancer
- Patients treated with first-line palliative chemotherapy
- Patients who are Danish speaking
- Patients 18 years of age or older
- Patients who are cognitively well-functioning
You will not qualify if you...
- Patients not using electronic mail
- Patients with dementia
- Patients not able to comply with the study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks
Participants receive an individualized nutritional intervention delivered by a clinical dietitian from the start and throughout palliative chemotherapy treatment.
Visits aligned with baseline, week 12, and week 24 assessments
Duration - Up to 1 year after treatment initiation
Participants are monitored for survival and treatment outcomes up to one year after starting the treatment.
Follow-up contacts may vary; specific visit schedule not defined
Trial Site Locations
Total: 1 location
1
Gødstrup Hospital
Herning, Denmark, 7400
Actively Recruiting
Research Team
K
Kirstine Guld Frederiksen, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here