Clinical trial · Interventional
Study to Assess the Effectiveness of a Omega-3 Enriched Supplement on Chemotherapy Tolerance in Colon Cancer Patients
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
NCT00398333CI-TRIAL-00010864terminatedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Impossibility to accomplish the sample size in assigned time.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Eicosapentaenoic acid enriched nutritional supplement | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Eicosapentaenoic acid enriched nutritional supplement
- interventionNames
- Dietary Supplement: Eicosapentaenoic acid enriched nutritional supplement
- type
- NO_INTERVENTION
- label
- No supplementation
Primary outcomes (1)
- 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.
- timeFrame
- 3 months
Secondary outcomes (2)
- measure
- To assess the influence of the nutritional status over the tolerance to the antineoplastic treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.
References
Publications (1)
- RESULTTrabal 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. PMID 21336429