Fish Oil Supplementation in Cancer Patients - Capsules or in Nutritional Supplements. A Controlled Trial of Compliance.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Copenhagen
- Enrollment
- 41
- Locations
- 1
- Primary Endpoint
- Compliance
Study Overview
Brief Summary
Several studies indicate beneficial effects of eicosapentanoic acid (EPA) on cancer cachexia. However, compliance is generally low. This case control study is conducted in order to investigate if compliance depends upon the physical properties of the supplement (capsules vs. drinks). In order to further investigate how compliance can be improved, a possible correlation between sideeffects and rate of increased polyunsaturated fatty acid concentration in blood is also tested
Detailed Description
Patients with abdominal cancer in active chemotherapeutic were allocated to either EPA in an oral nutritional drink (commercial) or capsules with fish oil. The dose of EPA was the same in both groups, and diets were adjusted as iso-caloric. Compliance to the fish oil treatment was the primary outcome. Blood concentrations of EPA secondary.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Masking Description
pseudo-anonymized
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients receiving chemotherapy on Rigshospitalet due to colorectal cancer
- •Not terminally ill
- •Subjects must be18 years of age (or older)
Exclusion Criteria
- •Subjects who do not read/speak/understand Danish
- •Familial hypercholesterolemia
- •Predialytic patients (GFR < 15 ml/min/1,73 m2 or creatinine ≥ 500 mmol/L)
- •Use of blood thinners
- •Bleeder's disease
Arms & Interventions
Capsules
Dietary Supplement: Möllers Omega-3 Ekstra Sterk
Intervention: Möllers Omega-3 Ekstra Sterk (Dietary Supplement)
Drink
Dietary Supplement: Nutrifriend Cachexia
Intervention: Nutrifriend Cachexia (Dietary Supplement)
Outcomes
Primary Outcomes
Compliance
Time Frame: 4 weeks
Number of Capsules and bottles counted
Secondary Outcomes
- Erythrocyte concentration of EPA(4 weeks)
Investigators
Jens Rikardt Andersen
Associated Professor
University of Copenhagen