ComplianceNCT03751384
Improvement of Compliance for High Doses of EPA Amongst Patients With Colorectal Cancer
A study testing Möllers Omega-3 Ekstra Sterk and Nutrifriend Cachexia in people with Compliance and Abdominal Cancer, run by University of Copenhagen at 1 site in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Compliance, Abdominal Cancer
- What is being tested?
- Möllers Omega-3 Ekstra Sterk and Nutrifriend Cachexia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteDenmark
- Study dates
- 18 May 2015to 10 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients receiving chemotherapy on Rigshospitalet due to colorectal cancer
- Not terminally ill
- Subjects must be18 years of age (or older)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Fish Oil Supplementation in Cancer Patients - Capsules or in Nutritional Supplements. A Controlled Trial of Compliance.
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
Read the 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.
- Conditions
- Compliance, Abdominal Cancer
- Being tested
- Möllers Omega-3 Ekstra Sterk, Nutrifriend Cachexia
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Möllers Omega-3 Ekstra SterkDietary supplement
Nutrifriend CachexiaDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Capsules | Experimental | Dietary Supplement: Möllers Omega-3 Ekstra Sterk Receives: Dietary Supplement: Möllers Omega-3 Ekstra Sterk |
| Drink | Active comparator | Dietary Supplement: Nutrifriend Cachexia Receives: Dietary Supplement: Nutrifriend Cachexia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance
Number of Capsules and bottles counted
Measured: 4 weeks
Secondary outcomes (1)
Erythrocyte concentration of EPA
Concentration measured on isolated erythrocytes
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start18 May 2015
- Primary completion25 Sep 2017
- Study completion10 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ComplianceStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Allocation, not randomized
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, Jens Rikardt Andersen, University of Copenhagen
- Investigators
- Jens R Andersen, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03751384
- Sponsor's protocol ID
- H-15000693
- Status last verified
- Nov 2018
- First submitted
- 16 Nov 2018
- Last updated
- 23 Nov 2018
- Results posted
- No
- Individual data sharing
- No
Publications
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.
PubMed 31987122
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fish Oil Supplementation in Cancer Patients - Capsules or in Nutritional Supplements. A Controlled Trial of Compliance.
- ClinicalTrials.gov ID
- NCT03751384
- Acronym / sponsor ID
- H-15000693
- Conditions
- Compliance, Abdominal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- 18 May 2015 (actual)
- Primary completion
- 25 Sep 2017 (actual)
- Study completion
- 10 Nov 2018 (actual)
- First posted
- 23 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Allocation, not randomized
| Arm | Type | Receives |
|---|---|---|
| Capsules | Experimental | Dietary Supplement: Möllers Omega-3 Ekstra SterkDietary Supplement: Möllers Omega-3 Ekstra Sterk |
| Drink | Active comparator | Dietary Supplement: Nutrifriend CachexiaDietary Supplement: Nutrifriend Cachexia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients receiving chemotherapy on Rigshospitalet due to colorectal cancer
- Not terminally ill
- Subjects must be18 years of age (or older)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Möllers Omega-3 Ekstra Sterk | Dietary supplement | Capsules |
| Nutrifriend Cachexia | Dietary supplement | Drink |
Primary outcome
Compliance
Time frame: 4 weeks
Number of Capsules and bottles counted
1 secondary outcome
Erythrocyte concentration of EPA
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2018.
- Derived from this study: PubMed 31987122Schmidt 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens R Andersen principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Möllers Omega-3 Ekstra Sterk and Nutrifriend Cachexia in people with Compliance and Abdominal Cancer, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03751384, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2018.