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

Abdominal Cancer Clinical Trial

Official title:

Fish Oil Supplementation in Cancer Patients - Capsules or in Nutritional Supplements. A Controlled Trial of Compliance.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03751384
• Other study ID #: H-15000693
• Status: Completed
• Phase: N/A
• Start date: May 18, 2015
• Est. completion date: November 10, 2018

Study information

• Verified date: November 2018
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: November 10, 2018
• Est. primary completion date: September 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Cancer
• Compliance

Intervention

Dietary Supplement:
• Möllers Omega-3 Ekstra Sterk

• Nutrifriend Cachexia

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance	Number of Capsules and bottles counted	4 weeks
Secondary	Erythrocyte concentration of EPA	Concentration measured on isolated erythrocytes	4 weeks