Early individualized nutrition for people with cancer starting palliative chemotherapy
Early Nutritional Intervention to Prevent Malnutrition in Patients With Cancer Receiving Palliative Chemotherapy in an Outpatient Setting
NA · Gødstrup Hospital · NCT06141785
This study tries to see if starting individualized nutrition support when people begin palliative chemotherapy helps maintain weight, muscle, quality of life, and treatment tolerance for patients with lung, pancreatic, ovarian, or colorectal cancer.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Gødstrup Hospital (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Herning) |
| Trial ID | NCT06141785 on ClinicalTrials.gov |
What this trial studies
This interventional study compares newly diagnosed patients with lung, pancreatic, ovarian, or colorectal cancer who receive individualized nutritional counseling from a clinical dietitian during first-line palliative chemotherapy to a historical control cohort receiving usual care. The intervention is tailored to each participant's nutritional needs, food preferences, nutrition-impact symptoms, and smell/taste changes and is delivered from treatment initiation throughout the treatment trajectory. The primary endpoint is change in body weight, with secondary endpoints including quality of life, survival, muscle mass, performance status, physical function, nutritional risk, and treatment tolerance. Data are collected at baseline and after 12 and 24 weeks using clinical measures and patient-reported outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18) who are Danish-speaking, cognitively intact, newly diagnosed with lung, pancreatic, ovarian, or colorectal cancer, and starting first-line palliative chemotherapy.
Not a fit: Patients not receiving palliative chemotherapy, those already well-nourished without risk of weight loss, or those unable to participate in follow-up (for example due to dementia, lack of email, or non-Danish speakers) are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the intervention could help patients maintain or gain weight, preserve muscle and physical function, improve quality of life, and better tolerate chemotherapy.
How similar studies have performed: Previous trials and clinical guidance indicate individualized nutritional support can improve weight, muscle mass, and quality of life in cancer patients, but robust data specifically at the initiation of palliative chemotherapy are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * patients who are cognitive well-functioning Exclusion Criteria: * Patients not using electronic mail * patients with dementia * patients not able to comply with the study protocol
Where this trial is running
Herning
- Gødstrup Hospital — Herning, Denmark (RECRUITING)
Study contacts
- Study coordinator: Kirstine Guld Frederiksen, MSc
- Email: kirsfe@rm.dk
- Phone: 24248914
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Nutritional Intervention, Cancer, Malnutrition, Nutritional interventions, Dietetics, Nutrition