Clinical trial · Interventional
Effect of Enteral Nutrition Rich in Eicosapentaenoic Acid (EPA) on Patients Receiving Chemotherapy for GI Tumor
Phase 3 Study of Enteral Nutrition Rich in Eicosapentaenoic Acid in Patients Receiving Chemotherapy for Gastric Cancer or Colorectal Cancer
NCT01048463CI-TRIAL-00005592unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Malnutrition is frequently seen in patients on chemotherapy suffering from gastric/colorectal cancer and may worsen the outcome. EPA, a sort of ω-3 PUFA, can modulate immune system. EPA also antagonizes metabolic and inflammatory changes induced by the tumor. This study is to test whether EPA, in combination with enteral nutrition, can improve nutritional/immunologic status, quality of life, and reduce chemotherapy related side effects of these patients.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| HDEPA | Drug | — | UNRESOLVED |
| LDEPA | Drug | — | UNRESOLVED |
| Nutriall | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- PLACEBO_COMPARATOR
- label
- EN
- description
- The subjects take in 150g of Nutriall per day. Oral administration of the liquid is divided into 3 times per day. The treatment lasts for 21d. During the test period patients are treated with the first course of XELOX.
- interventionNames
- Drug: Nutriall
- Drug: Placebo
- Drug: Chemotherapy
- type
- EXPERIMENTAL
- label
- ENLDEPA
- description
- The subjects take in the same dose of Nutriall for the same duration as those in EN group. In addition, they take in 3 grams of EPA per day during the 21 days of treatment. The patients are treated with the first course of XELOX.
- interventionNames
- Drug: Nutriall
- Drug: LDEPA
- Drug: Chemotherapy
- type
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * The cases have undergone radical excision on gastric cancer or colorectal cancer. * Without contraindication for chemotherapy. * Eligible for postoperative adjuvant XELOX chemotherapy. * Capable of taking in food or drug orally. * Without severe absorption dysfunction * Able and willing to give written, informed consent Exclusion Criteria: * Comorbidities: diseases of hematology or immunology system; hepatic or renal dysfunction; metabolic diseases. * BMI\>35kg/m2 * Life expectancy≤3mo * The chemotherapy treatment is palliative. * The patient has received radiotherapy or neoadjuvant chemotherapy prior to the operation.
References
Publications (13)
- BACKGROUNDBarber MD, Fearon KC. Tolerance and incorporation of a high-dose eicosapentaenoic acid diester emulsion by patients with pancreatic cancer cachexia. Lipids. 2001 Apr;36(4):347-51. doi: 10.1007/s11745-001-0726-4. PMID 11383684
- BACKGROUNDBayram I, Erbey F, Celik N, Nelson JL, Tanyeli A. The use of a protein and energy dense eicosapentaenoic acid containing supplement for malignancy-related weight loss in children. Pediatr Blood Cancer. 2009 May;52(5):571-4. doi: 10.1002/pbc.21852. PMID 19090549
- BACKGROUNDCalviello G, Di Nicuolo F, Serini S, Piccioni E, Boninsegna A, Maggiano N, Ranelletti FO, Palozza P. Docosahexaenoic acid enhances the susceptibility of human colorectal cancer cells to 5-fluorouracil. Cancer Chemother Pharmacol. 2005 Jan;55(1):12-20. doi: 10.1007/s00280-004-0846-6. Epub 2004 Sep 10. PMID 15365767
- BACKGROUNDCrooks V, Waller S, Smith T, Hahn TJ. The use of the Karnofsky Performance Scale in determining outcomes and risk in geriatric outpatients. J Gerontol. 1991 Jul;46(4):M139-44. doi: 10.1093/geronj/46.4.m139. PMID 2071835
- BACKGROUNDElia M, Van Bokhorst-de van der Schueren MA, Garvey J, Goedhart A, Lundholm K, Nitenberg G, Stratton RJ. Enteral (oral or tube administration) nutritional support and eicosapentaenoic acid in patients with cancer: a systematic review. Int J Oncol. 2006 Jan;28(1):5-23. doi: 10.3892/ijo.28.1.5. PMID 16327975
- BACKGROUNDGorjao R, Azevedo-Martins AK, Rodrigues HG, Abdulkader F, Arcisio-Miranda M, Procopio J, Curi R. Comparative effects of DHA and EPA on cell function. Pharmacol Ther. 2009 Apr;122(1):56-64. doi: 10.1016/j.pharmthera.2009.01.004. Epub 2009 Feb 12. PMID 19318040
- BACKGROUNDPratt VC, Watanabe S, Bruera E, Mackey J, Clandinin MT, Baracos VE, Field CJ. Plasma and neutrophil fatty acid composition in advanced cancer patients and response to fish oil supplementation. Br J Cancer. 2002 Dec 2;87(12):1370-8. doi: 10.1038/sj.bjc.6600659.