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

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ClinicalTrials.gov Identifier: NCT03751384
Recruitment Status : Completed
First Posted : November 23, 2018
Last Update Posted : November 23, 2018
Sponsor:
Collaborator:
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Jens Rikardt Andersen, University of Copenhagen

Study Description
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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

Condition or disease Intervention/treatment Phase
Compliance Abdominal Cancer Dietary Supplement: Möllers Omega-3 Ekstra Sterk Dietary Supplement: Nutrifriend Cachexia Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Allocation, not randomized
Masking: Single (Outcomes Assessor)
Masking Description: pseudo-anonymized
Primary Purpose: Supportive Care
Official Title: Fish Oil Supplementation in Cancer Patients - Capsules or in Nutritional Supplements. A Controlled Trial of Compliance.
Actual Study Start Date : May 18, 2015
Actual Primary Completion Date : September 25, 2017
Actual Study Completion Date : November 10, 2018

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Capsules
Dietary Supplement: Möllers Omega-3 Ekstra Sterk
 Dietary Supplement: Möllers Omega-3 Ekstra Sterk
Active Comparator: Drink
Dietary Supplement: Nutrifriend Cachexia
 Dietary Supplement: Nutrifriend Cachexia


Outcome Measures
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Primary Outcome Measures :
  1. Compliance [ Time Frame: 4 weeks ]
    Number of Capsules and bottles counted


Secondary Outcome Measures :
  1. Erythrocyte concentration of EPA [ Time Frame: 4 weeks ]
    Concentration measured on isolated erythrocytes


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03751384


Locations
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Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
University of Copenhagen
Rigshospitalet, Denmark
Investigators
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Principal Investigator: Jens R Andersen University of Copenhagen
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jens Rikardt Andersen, Associated Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT03751384    
Other Study ID Numbers: H-15000693
First Posted: November 23, 2018    Key Record Dates
Last Update Posted: November 23, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No