Cancer CachexiaPhase 4NCT04699760
The Effects of n-3 LCPUFAs in Patients With Colorectal Cancer
A Phase 4 study testing Fish Oil in people with Cancer Cachexia and Side Effects, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The aim of this study is to determine the effects of n-3 PUFAs on weight, physical funktion and quality of life in patients with colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cancer Cachexia, Side Effects, Quality of Life
- What is being tested?
- Fish Oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2015to Sep 2015
- Phase
- Phase 4
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years
- Patients with diagnosed colorectal cancer with metastases treated with chemotherapy on Rigshospitalet, Copenhagen
Who cannot join
- < 18 years
- Patients in palliative care
- patients with haemophilia
- Patiens in treatment of anti-coagulation
- Patients with genetic hyperkolesterolemia
- Pre-dialytic patients (GFR<15ml/min/1,73m2 eller kreatinin ≥500 mmol/L)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-blinded, Randomized, Controlled Trial About the Effects of n-3 LCPUFAs on Weight and Functional Status in Patients With Colorectal Cancer.
The aim of this study is to determine the effects of n-3 PUFAs on weight, physical funktion and quality of life in patients with colorectal cancer.
Read the detailed description
Primary outcomes:
- Weight
- Physical function
- Hand-grip strength
Secondary outcomes:
- Quality of life
- Mid-upperarm circumference
- Incorporation of n-3 PUFAs into cell membranes
- Conditions
- Cancer Cachexia, Side Effects, Quality of Life
- Being tested
- Fish Oil, Placebo
- Keywords
- cancer, nutrition, fish oil
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish OilDietary supplement
Also called Smart Fish - cancer cachexia
8 weeks, 2.2 G EPA/day
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Nutritional supplement without fish oil Receives: Dietary Supplement: Placebo |
| Fish oil | Active comparator | Nutritional supplement with fish oil Receives: Dietary Supplement: Fish Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Difference in weight (kg) from inclusion to 8 week status
Measured: 8 weeks
Secondary outcomes (2)
quality of Life score
score - difference from inclusion to 8 week status (EORTC QLQ-C30 questionnaire)
Measured: 8 weeks
Performance status - common daily abilities
combined scale - score - ADL
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study startApr 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer CachexiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- 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
- NCT04699760
- Sponsor's protocol ID
- H-4-2014-131
- Status last verified
- Jan 2021
- First submitted
- 23 Dec 2020
- Last updated
- 7 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-blinded, Randomized, Controlled Trial About the Effects of n-3 LCPUFAs on Weight and Functional Status in Patients With Colorectal Cancer.
- ClinicalTrials.gov ID
- NCT04699760
- Acronym / sponsor ID
- H-4-2014-131
- Conditions
- Cancer Cachexia, Side Effects, Quality of Life
- Keywords
- cancer, nutrition, fish oil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 7 Jan 2021 (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.
The aim of this study is to determine the effects of n-3 PUFAs on weight, physical funktion and quality of life in patients with colorectal cancer.
Detailed description
Primary outcomes:
- Weight
- Physical function
- Hand-grip strength
Secondary outcomes:
- Quality of life
- Mid-upperarm circumference
- Incorporation of n-3 PUFAs into cell membranes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboNutritional supplement without fish oil |
| Fish oil | Active comparator | Dietary Supplement: Fish OilNutritional supplement with fish oil |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ≥18 years
- Patients with diagnosed colorectal cancer with metastases treated with chemotherapy on Rigshospitalet, Copenhagen
Key exclusion criteria (6 listed)
- < 18 years
- Patients in palliative care
- patients with haemophilia
- Patiens in treatment of anti-coagulation
- Patients with genetic hyperkolesterolemia
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 |
|---|---|---|
| Fish OilAlso: Smart Fish - cancer cachexia8 weeks, 2.2 G EPA/day | Dietary supplement | Fish oil |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
Weight loss
Time frame: 8 weeks
Difference in weight (kg) from inclusion to 8 week status
2 secondary outcomes
quality of Life score
Time frame: 8 weeks
Performance status - common daily abilities
Time frame: 8 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 7 Jan 2021.
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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 Phase 4 study testing Fish Oil in people with Cancer Cachexia and Side Effects, 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 2 inclusion and 6 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 7 Jan 2021. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Weight loss (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jan 2021.