Clinical trial · Interventional
Effects of EPA Supplementation on Patients With Unresectable Hepatocellular Carcinoma.
Effects of Nutritional Supplementation With Eicosapentaenoic Acid (EPA) on Body Composition and Systemic Pro-inflammatory and Pro-resolving Mediators in Patients Diagnosed With Unresectable Hepatocellular Carcinoma.
NCT07664007CI-TRIAL-00115569completedN/AClinicalTrials.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)
Dietary intervention with eicosapentaenoic acid combined with chemotherapy may shift inflammatory mediators toward resolution in non-resectable hepatocarcinoma and help to preserve muscle mass.
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 |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Eicosapentaenoic acid oral lipidic emulsion | Dietary Supplement | — | UNRESOLVED |
| Pacebo oral lipidic emulsion | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention group
- description
- Patients with unresectable hepatocellular carcinoma (HCC) were given 3 grams/day of an oral lipidic emulsion of eicosapentaenoic acid in addition to their oncologic care during 12 weeks.
- interventionNames
- Dietary Supplement: Eicosapentaenoic acid oral lipidic emulsion
- type
- PLACEBO_COMPARATOR
- label
- Control group
- description
- Patients with unresectable hepatocellular carcinoma (HCC) were given a placebo oral lipidic emulsion in addition to their oncologic care during 12 weeks.
- interventionNames
- Dietary Supplement: Pacebo oral lipidic emulsion
Primary outcomes (1)
- measure
- Effect of EPA supplementation on muscle mass
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Participants diagnosed with unresectable HCC, candidates for systemic treatment with Sorafenib or similar agents. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. * Life expectancy \> 8 weeks. * Not eligible for curative treatment (surgical resection/ablative therapy/liver transplantation). * Not having a history of previous or concomitant malignancy except when a disease-free interval \> 5 years had been documented. * Not receiving any other systemic antitumor agents (docetaxel, doxorubicin, irinotecan). Exclusion Criteria: * Allergy to omega-3 acid or fish-derived products. * Psychological or medical conditions that can interfere with study participation or the ability to provide informed consent. * Drug abuse (except for alcohol). * Any experimental therapy within 30 days prior to study entry. * Recurrent epistaxis
References
Publications (12)
- BACKGROUNDBlazeby JM, Currie E, Zee BC, Chie WC, Poon RT, Garden OJ; EORTC Quality of Life Group. Development of a questionnaire module to supplement the EORTC QLQ-C30 to assess quality of life in patients with hepatocellular carcinoma, the EORTC QLQ-HCC18. Eur J Cancer. 2004 Nov;40(16):2439-44. doi: 10.1016/j.ejca.2004.06.033. PMID 15519517
- BACKGROUNDBauer J, Capra S, Ferguson M. Use of the scored Patient-Generated Subjective Global Assessment (PG-SGA) as a nutrition assessment tool in patients with cancer. Eur J Clin Nutr. 2002 Aug;56(8):779-85. doi: 10.1038/sj.ejcn.1601412. PMID 12122555
- BACKGROUNDMartin L, Birdsell L, Macdonald N, Reiman T, Clandinin MT, McCargar LJ, Murphy R, Ghosh S, Sawyer MB, Baracos VE. Cancer cachexia in the age of obesity: skeletal muscle depletion is a powerful prognostic factor, independent of body mass index. J Clin Oncol. 2013 Apr 20;31(12):1539-47. doi: 10.1200/JCO.2012.45.2722. Epub 2013 Mar 25. PMID 23530101
- BACKGROUNDCarey EJ, Lai JC, Wang CW, Dasarathy S, Lobach I, Montano-Loza AJ, Dunn MA; Fitness, Life Enhancement, and Exercise in Liver Transplantation Consortium. A multicenter study to define sarcopenia in patients with end-stage liver disease. Liver Transpl. 2017 May;23(5):625-633. doi: 10.1002/lt.24750. PMID 28240805
- BACKGROUNDLim K, Han C, Dai Y, Shen M, Wu T. Omega-3 polyunsaturated fatty acids inhibit hepatocellular carcinoma cell growth through blocking beta-catenin and cyclooxygenase-2. Mol Cancer Ther. 2009 Nov;8(11):3046-55. doi: 10.1158/1535-7163.MCT-09-0551. Epub 2009 Nov 3. PMID 19887546
- BACKGROUNDIkeda T, Tozuka S, Hasumura Y, Takeuchi J. Prostaglandin-E-producing hepatocellular carcinoma with hypercalcemia. Cancer. 1988 May 1;61(9):1813-4. doi: 10.1002/1097-0142(19880501)61:93.0.co;2-u. PMID 2833340
- BACKGROUNDOnesti JK, Guttridge DC. Inflammation based regulation of cancer cachexia. Biomed Res Int. 2014;2014:168407. doi: 10.1155/2014/168407. Epub 2014 May 4.