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

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University of Copenhagen

Status

Completed

Conditions

Compliance
Abdominal Cancer

Treatments

Dietary Supplement: Möllers Omega-3 Ekstra Sterk
Dietary Supplement: Nutrifriend Cachexia

Study type

Interventional

Funder types

Other

Identifiers

NCT03751384
H-15000693

Details and patient eligibility

About

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

Full 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.

Enrollment

41 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

41 participants in 2 patient groups

Capsules
Experimental group
Description:
Dietary Supplement: Möllers Omega-3 Ekstra Sterk
Treatment:
Dietary Supplement: Möllers Omega-3 Ekstra Sterk
Drink
Active Comparator group
Description:
Dietary Supplement: Nutrifriend Cachexia
Treatment:
Dietary Supplement: Nutrifriend Cachexia

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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