Colorectal NeoplasmsPhase 4NCT00398333
Study to Assess the Effectiveness of a Omega-3 Enriched Supplement on Chemotherapy Tolerance in Colon Cancer Patients
A Phase 4 study testing Eicosapentaenoic acid enriched nutritional supplement in people with Colorectal Neoplasms, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
The purpose of this study is to determine if a nutritional supplement enriched in omega-3 fatty acids is effective in improving the tolerance to chemotherapy treatment and improves quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Eicosapentaenoic acid enriched nutritional supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2005to Mar 2008
- 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
- Patients diagnosed of metastatic colon adenocarcinoma that are going to receive first line chemotherapy treatment in the oncology day hospital.
- Age over 18 years old.
Who cannot join
- Patients diagnosed of colon cancer are receiving second line chemotherapy.
- Antecedents of other malignant tumors with the exception of basocellular epithelioma.
- Chronic renal failure (Creatinine > 1.7).
- Previous diabetes mellitus.
- Obesity (IMC > 30)
- Medical conditions that imply hepatic encephalopathy, or ascites.
Show all 14Show fewer
- Severe malnutrition according to the classification of the Subjective Global Assessment (SGA) or a BMI < 16.5.
- Major psychiatric disorder.
- Patients receiving enteral or parenteral nutrition.
- Contraindications for the indication of the nutritional supplement: Galactosemia.
- Seafood or seafood byproducts allergy.
- Patients taking drugs that affect the metabolism (anabolic steroids, orexigenic agents...).
- Absence of the informed consent form signed by the patient.
- Any patient who has disability to comply with the treatment or who has inability according to the researcher.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled, Open-label, Pilot Study to Assess the Effectiveness of a Nutritional Supplementation Enriched With Eicosapentaenoic Acid on Chemotherapy Tolerance in Patients With Advanced Colorectal Cancer
The purpose of this study is to determine if a nutritional supplement enriched in omega-3 fatty acids is effective in improving the tolerance to chemotherapy treatment and improves quality of life.
Read the detailed description
Colorectal cancer is one of the main causes of mortality in western countries. It is considered that in case of colorectal carcinoma, the frequency of weight loss at the moment of diagnosis is 54%. Undernourishment affects negatively the course of the illness and it confers a worse prognostic, increasing the morbidity and the mortality, while it entails an impairment in the quality of life of the patient.
There is a narrow relationship in the oncologic pathology between undernourishment and the pathology itself, drawing a common syndrome called cancerous cachexia. It is usual that patients subjected to chemotherapy present nutritional alterations due to the treatments' side effects.
With this study we want to assess the efficacy of a nutritional intervention with supplementation enriched in EPA to improve the tolerance to the antineoplastic treatment. As an index of tolerability to the chemotherapy treatment, it will be used the variation of changes in quality of life evaluated through the questionnaire EORTC QLQ-C30, using the parameters of global quality of life and physical function.
- Conditions
- Colorectal Neoplasms
- Being tested
- Eicosapentaenoic acid enriched nutritional supplement
- Keywords
- Colorectal Neoplasms, Eicosapentaenoic Acid, Quality of Life, Nutritional Status
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eicosapentaenoic acid enriched nutritional supplementDietary supplement
Also called Prosure
Oral intake of nutritional supplementation: a maximum of 480 mL or a minimum of 240 mL daily during the first 3 months of the study.
| Study group | Role | What they receive |
|---|---|---|
| Eicosapentaenoic acid enriched nutritional supplement | Experimental | Not described Receives: Dietary Supplement: Eicosapentaenoic acid enriched nutritional supplement |
| No supplementation | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the efficacy of a nutritional intervention with supplementation enriched in EPA to improve the tolerance to the antineoplastic treatment, using the variation in quality of life changes as the tolerability index.
Measured: 3 months
Secondary outcomes (2)
To assess the influence of the nutritional status over the tolerance to the antineoplastic treatment.
Measured: 6 months
To assess the effect of a nutritional supplement over the nutritional status of the patient with disseminated neoplastic illness.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2006 (estimated)
- Study startJun 2005
- Primary completionMar 2008
- Study completionMar 2008
Why it stopped: Impossibility to accomplish the sample size in assigned time.
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 Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Principal investigator, Pere Leyes, Hospital Clinic of Barcelona
- Investigators
- Pere Leyes, MD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00398333
- Sponsor's protocol ID
- EPA-05
- Other IDs
- EPA-05/ ACA-SPAI-05-05
- Status last verified
- Jun 2013
- First submitted
- 9 Nov 2006
- Last updated
- 20 Jun 2013
- Results posted
- No
Publications
Trabal J, Leyes P, Forga M, Maurel J. Potential usefulness of an EPA-enriched nutritional supplement on chemotherapy tolerability in cancer patients without overt malnutrition. Nutr Hosp. 2010 Sep-Oct;25(5):736-40.
PubMed 21336429
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled, Open-label, Pilot Study to Assess the Effectiveness of a Nutritional Supplementation Enriched With Eicosapentaenoic Acid on Chemotherapy Tolerance in Patients With Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00398333
- Acronym / sponsor ID
- EPA-05
- Conditions
- Colorectal Neoplasms
- Keywords
- Colorectal Neoplasms, Eicosapentaenoic Acid, Quality of Life, Nutritional Status
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Impossibility to accomplish the sample size in assigned time.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Jun 2005
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 10 Nov 2006 (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.
The purpose of this study is to determine if a nutritional supplement enriched in omega-3 fatty acids is effective in improving the tolerance to chemotherapy treatment and improves quality of life.
Detailed description
Colorectal cancer is one of the main causes of mortality in western countries. It is considered that in case of colorectal carcinoma, the frequency of weight loss at the moment of diagnosis is 54%. Undernourishment affects negatively the course of the illness and it confers a worse prognostic, increasing the morbidity and the mortality, while it entails an impairment in the quality of life of the patient.
There is a narrow relationship in the oncologic pathology between undernourishment and the pathology itself, drawing a common syndrome called cancerous cachexia. It is usual that patients subjected to chemotherapy present nutritional alterations due to the treatments' side effects.
With this study we want to assess the efficacy of a nutritional intervention with supplementation enriched in EPA to improve the tolerance to the antineoplastic treatment. As an index of tolerability to the chemotherapy treatment, it will be used the variation of changes in quality of life evaluated through the questionnaire EORTC QLQ-C30, using the parameters of global quality of life and physical function.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eicosapentaenoic acid enriched nutritional supplement | Experimental | Dietary Supplement: Eicosapentaenoic acid enriched nutritional supplement |
| No supplementation | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed of metastatic colon adenocarcinoma that are going to receive first line chemotherapy treatment in the oncology day hospital.
- Age over 18 years old.
Key exclusion criteria (14 listed)
- Patients diagnosed of colon cancer are receiving second line chemotherapy.
- Antecedents of other malignant tumors with the exception of basocellular epithelioma.
- Chronic renal failure (Creatinine > 1.7).
- Previous diabetes mellitus.
- Obesity (IMC > 30)
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 |
|---|---|---|
| Eicosapentaenoic acid enriched nutritional supplementAlso: ProsureOral intake of nutritional supplementation: a maximum of 480 mL or a minimum of 240 mL daily during the first 3 months of the study. | Dietary supplement | Eicosapentaenoic acid enriched nutritional supplement |
Primary outcome
To assess the efficacy of a nutritional intervention with supplementation enriched in EPA to improve the tolerance to the antineoplastic treatment, using the variation in quality of life changes as the tolerability index.
Time frame: 3 months
2 secondary outcomes
To assess the influence of the nutritional status over the tolerance to the antineoplastic treatment.
Time frame: 6 months
To assess the effect of a nutritional supplement over the nutritional status of the patient with disseminated neoplastic illness.
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Impossibility to accomplish the sample size in assigned time.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2013.
- Results publication: PubMed 21336429Trabal J, Leyes P, Forga M, Maurel J. Potential usefulness of an EPA-enriched nutritional supplement on chemotherapy tolerability in cancer patients without overt malnutrition. Nutr Hosp. 2010 Sep-Oct;25(5):736-40.
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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.
Pere Leyes, MD principal investigator
Hospital Clinic of Barcelona
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 Eicosapentaenoic acid enriched nutritional supplement in people with Colorectal Neoplasms, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 14 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: stopped early, as of the sponsor's last update on 20 Jun 2013. 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 Spain. 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 was stopped early (reason given: Impossibility to accomplish the sample size in assigned time.). Results are not available in the source record.
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?
To assess the efficacy of a nutritional intervention with supplementation enriched in EPA to improve the tolerance to the antineoplastic treatment, using the variation in quality of life changes as the tolerability index. (time frame: 3 months). 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 NCT00398333, 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 20 Jun 2013.