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.
1 other identifier
interventional
41
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 25, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 10, 2018
CompletedFirst Submitted
Initial submission to the registry
November 16, 2018
CompletedFirst Posted
Study publicly available on registry
November 23, 2018
CompletedNovember 23, 2018
November 1, 2018
2.4 years
November 16, 2018
November 21, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Compliance
Number of Capsules and bottles counted
4 weeks
Secondary Outcomes (1)
Erythrocyte concentration of EPA
4 weeks
Study Arms (2)
Capsules
EXPERIMENTALDietary Supplement: Möllers Omega-3 Ekstra Sterk
Drink
ACTIVE COMPARATORDietary Supplement: Nutrifriend Cachexia
Interventions
Eligibility Criteria
You may qualify if:
- Patients receiving chemotherapy on Rigshospitalet due to colorectal cancer
- Not terminally ill
- Subjects must be18 years of age (or older)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Copenhagenlead
- Rigshospitalet, Denmarkcollaborator
Study Sites (1)
Rigshospitalet
Copenhagen, 2100, Denmark
Related Publications (1)
Schmidt N, Moller G, Baeksgaard L, Osterlind K, Stark KD, Lauritzen L, Andersen JR. Fish oil supplementation in cancer patients. Capsules or nutritional drink supplements? A controlled study of compliance. Clin Nutr ESPEN. 2020 Feb;35:63-68. doi: 10.1016/j.clnesp.2019.12.004. Epub 2020 Jan 3.
PMID: 31987122DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jens R Andersen
University of Copenhagen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- pseudo-anonymized
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associated Professor
Study Record Dates
First Submitted
November 16, 2018
First Posted
November 23, 2018
Study Start
May 18, 2015
Primary Completion
September 25, 2017
Study Completion
November 10, 2018
Last Updated
November 23, 2018
Record last verified: 2018-11
Data Sharing
- IPD Sharing
- Will not share