Colorectal NeoplasmsPhase 4NCT00168987
Influence of an Oral Nutritional Supplement Rich in Omega-3 Fatty Acids on Functional State and Quality of Life in Malnourished Patients With Gastroenterological Tumors
A Phase 4 study testing oral nutritional supplement rich in eicosapentanoic acid in people with Colorectal Neoplasms and Hepatocellular Carcinoma, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Malnutrition is a frequent symptom of various malignant diseases and is frequently observed in patients with gastrointestinal tumors. Eicosapentanoic acid (EPA) has been introduced as specific and anticatabolic acting substrate in cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms, Hepatocellular Carcinoma, Cholangiocarcinoma
- What is being tested?
- oral nutritional supplement rich in eicosapentanoic acid
- Type of treatment
- Pill or oral medicine
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2005to Jun 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- malignant disease: colorectal neoplasm, hepatocellular carcinoma, cholangiocarcinoma
- palliative treatment of malignant disease: UICC stage >1
- impaired nutritional state: weight loss > 5% body weight in the preceding 6 months or subjective global assessment grade B (moderately malnourished) or grade C (severely malnourished)
- informed written consent
Who cannot join
- age < 18 years
- pregnancy
- exclusive enteral or parenteral nutrition
- taking of eicosapentanoic acid in form of fish oil capsules
- contraindications for oral nutrition (i.e. ileus, uncontrollable vomiting)
- terminal stage of disease with a life expectancy < 3 months
- missing or withdrawn consent
- simultaneous participation in another trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study: Randomized Controlled Trial on the Influence of an Oral Nutritional Supplement Rich in Omega-3 Fatty Acids on Functional State and Quality of Life in Malnourished Patients With Gastroenterological Tumors
Malnutrition is a frequent symptom of various malignant diseases and is frequently observed in patients with gastrointestinal tumors. Eicosapentanoic acid (EPA) has been introduced as specific and anticatabolic acting substrate in cancer patients. Only few randomized trials are available which investigated the effect of EPA in form of an EPA-enriched, protein- and energy-dense oral nutritional supplement mostly in patients with pancreatic carcinoma.
Therefore, the effect of an EPA-rich oral nutritional supplement for two months on functional state and quality of life in patients with other gastroenterological tumors and weight loss is investigated in this randomized prospective trial.
- Being tested
- oral nutritional supplement rich in eicosapentanoic acid
- Keywords
- oral nutritional supplement, eicosapentanoic acid, gastroenterological tumors, muscle function, quality of life, body composition
- Medical subject headings
- Colorectal Neoplasms, Carcinoma, Hepatocellular, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral nutritional supplement rich in eicosapentanoic acidDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement of muscle function (hand grip strength, respiratory muscle function) at two months
improvement of cognitive function at two months
improvement of quality of life at two months
Secondary outcomes (2)
tolerance of the oral nutritional supplement
improvement of nutritional state (body weight, muscle mass, body cell mass, phase angle, serum albumin)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJan 2005
- Primary completionNov 2006
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Pfrimmer Nutricia GmbH, Erlangen , Germany
- Investigators
- Matthias Pirlich, MD, Principal investigator, Charite University Hospital, Dept. of Gastroenterology, Hepatology and Endocrinology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00168987
- Sponsor's protocol ID
- EA1/174/05
- Status last verified
- May 2008
- First submitted
- 13 Sep 2005
- Last updated
- 9 May 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Randomized Controlled Trial on the Influence of an Oral Nutritional Supplement Rich in Omega-3 Fatty Acids on Functional State and Quality of Life in Malnourished Patients With Gastroenterological Tumors
- ClinicalTrials.gov ID
- NCT00168987
- Acronym / sponsor ID
- EA1/174/05
- Keywords
- oral nutritional supplement, eicosapentanoic acid, gastroenterological tumors, muscle function, quality of life, body composition
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Pfrimmer Nutricia GmbH, Erlangen , Germany
- Study start
- Jan 2005
- Primary completion
- Nov 2006 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 15 Sep 2005 (estimated)
- 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.
Malnutrition is a frequent symptom of various malignant diseases and is frequently observed in patients with gastrointestinal tumors. Eicosapentanoic acid (EPA) has been introduced as specific and anticatabolic acting substrate in cancer patients. Only few randomized trials are available which investigated the effect of EPA in form of an EPA-enriched, protein- and energy-dense oral nutritional supplement mostly in patients with pancreatic carcinoma.
Therefore, the effect of an EPA-rich oral nutritional supplement for two months on functional state and quality of life in patients with other gastroenterological tumors and weight loss is investigated in this randomized prospective trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- malignant disease: colorectal neoplasm, hepatocellular carcinoma, cholangiocarcinoma
- palliative treatment of malignant disease: UICC stage >1
- impaired nutritional state: weight loss > 5% body weight in the preceding 6 months or subjective global assessment grade B (moderately malnourished) or grade C (severely malnourished)
- informed written consent
Key exclusion criteria (8 listed)
- age < 18 years
- pregnancy
- exclusive enteral or parenteral nutrition
- taking of eicosapentanoic acid in form of fish oil capsules
- contraindications for oral nutrition (i.e. ileus, uncontrollable vomiting)
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 |
|---|---|---|
| oral nutritional supplement rich in eicosapentanoic acid | Drug | – |
Primary outcome
improvement of muscle function (hand grip strength, respiratory muscle function) at two months
improvement of cognitive function at two months
improvement of quality of life at two months
2 secondary outcomes
tolerance of the oral nutritional supplement
improvement of nutritional state (body weight, muscle mass, body cell mass, phase angle, serum albumin)
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 9 May 2008.
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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.
Matthias Pirlich, MD principal investigator
Charite University Hospital, Dept. of Gastroenterology, Hepatology and Endocrinology
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 oral nutritional supplement rich in eicosapentanoic acid in people with Colorectal Neoplasms and Hepatocellular Carcinoma, run by Charite University, Berlin, Germany at 1 site in Germany.
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 4 inclusion and 8 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 9 May 2008. 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 Germany. 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.
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?
improvement of muscle function (hand grip strength, respiratory muscle function) at two months. The study lists 3 primary outcomes in all. 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 9 May 2008.