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OpenTrials
Completed

NCT Number: NCT03751384

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

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

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Key information

Conditions

Compliance Abdominal Cancer Behavior Health Behavior Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Möllers Omega-3 Ekstra Sterk

Dietary Supplement

Nutrifriend Cachexia

Dietary Supplement

Primary outcomes

  1. Compliance

    Time frame: 4 weeks

    Number of Capsules and bottles counted

Secondary outcomes

  1. Erythrocyte concentration of EPA

    Time frame: 4 weeks

    Concentration measured on isolated erythrocytes

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Rigshospitalet, Denmark

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Nov 23, 2018
Registry last updated
Nov 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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