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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03751384
Enrollment
41
Registered
2018-11-23
Start date
2015-05-18
Completion date
2018-11-10
Last updated
2018-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Compliance, Abdominal Cancer

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.

Interventions

DIETARY_SUPPLEMENTMöllers Omega-3 Ekstra Sterk
DIETARY_SUPPLEMENTNutrifriend Cachexia

Sponsors

Rigshospitalet, Denmark
CollaboratorOTHER
University of Copenhagen
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Masking description

pseudo-anonymized

Intervention model description

Allocation, not randomized

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Compliance4 weeksNumber of Capsules and bottles counted

Secondary

MeasureTime frameDescription
Erythrocyte concentration of EPA4 weeksConcentration measured on isolated erythrocytes

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026