Improvement of Compliance for High Doses of EPA Amongst Patients With Colorectal Cancer

Not Applicable

Completed

• Conditions: Compliance; Abdominal Cancer
• Interventions: Dietary Supplement: Nutrifriend Cachexia; Dietary Supplement: Möllers Omega-3 Ekstra Sterk

• Registration Number: NCT03751384
• Lead Sponsor: University of Copenhagen

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 Timeline

• Study Start: 2015-05-18
• Primary Completion: 2017-09-25
• Status Verified: 2018-11
• Study Completion: 2018-11-10
• Study First Submitted: 2018-11-16
• Study First Submitted QC: 2018-11-21
• Last Update Submitted: 2018-11-21
• Study First Posted: 2018-11-23
• Last Update Posted: 2018-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drink	Nutrifriend Cachexia	Dietary Supplement: Nutrifriend Cachexia
Capsules	Möllers Omega-3 Ekstra Sterk	Dietary Supplement: Möllers Omega-3 Ekstra Sterk

Primary Outcome Measures

Name	Time	Method
Compliance	4 weeks	Number of Capsules and bottles counted

Secondary Outcome Measures

Name	Time	Method
Erythrocyte concentration of EPA	4 weeks	Concentration measured on isolated erythrocytes

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark