Effects of EPA Supplementation on Patients With Unresectable Hepatocellular Carcinoma.

NCT07664007 | Completed

• 1 other identifier: LMP225_18
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Hepatocellular Carcinoma

Keywords

inflammation; cachexia; eicosapentaenoic acid; lipid mediator

Outcome Measures

Primary Outcomes (1)

• Effect of EPA supplementation on muscle mass

  Muscle mass is assessed by calculating the skeletal muscle index using computed tomography, based on a single axial slice at the L3 level. The SliceOmatic software (TomoVision) is used for the calculations. Sarcopenia is evaluated using two criteria: Carey reference values for end-stage liver disease patients awaiting transplantation, and Martin reference values for oncology patients.

  At baseline, and at 12 weeks (study completion)

Secondary Outcomes (9)

• Evolution of nutritional status.

  At baseline, at 6 weeks, and at 12 weeks (study completion)

• Effect of EPA supplementation on quality of life assessed using the EORTC-QLQ-30.

  At baseline, at 6 weeks, and at 12 weeks (study completion)

• Change in the quality of life assessed using the EORTC-QLQ-HCC18.

  At baseline, at 6 weeks, and at 12 weeks (study completion)

• Effect of EPA supplementation on plasma and serum profiles of pro-inflammatory and pro-resolving lipid mediators.

  At baseline, and at 12 weeks (study completion)

• Change in C-reactive protein (CRP) concentration upon supplementation.

  At baseline, and at 12 weeks (study completion)

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Dietary Supplement: Eicosapentaenoic acid oral lipidic emulsion

Control group

PLACEBO COMPARATOR

Patients with unresectable hepatocellular carcinoma (HCC) were given a placebo oral lipidic emulsion in addition to their oncologic care during 12 weeks.

Dietary Supplement: Pacebo oral lipidic emulsion

Interventions

Eicosapentaenoic acid oral lipidic emulsion DIETARY_SUPPLEMENT

1 sachet/day of 20 ml containing 3g EPA during 12 weeks

Intervention group

Pacebo oral lipidic emulsion DIETARY_SUPPLEMENT

1 sachet/day of 20 ml of placebo during 12 weeks

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto de Investigación Sanitaria Aragón: lead
• Hospital Clínico Universitario Lozano Blesa: collaborator
• Solutex GC S.L.: collaborator

Study Sites (1)

Hospital Clínico Universitario Lozano Blesa. IIS Aragón

Zaragoza, Zaragoza, 50009, Spain

Location

Related Publications (12)

• Blazeby 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 BACKGROUND

• Bauer 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 BACKGROUND

• Martin 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 BACKGROUND

• Carey 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 BACKGROUND

• Lim 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 BACKGROUND

• Ikeda 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 BACKGROUND

• Onesti JK, Guttridge DC. Inflammation based regulation of cancer cachexia. Biomed Res Int. 2014;2014:168407. doi: 10.1155/2014/168407. Epub 2014 May 4.

  PMID: 24877061 BACKGROUND

• Ozola Zalite I, Zykus R, Francisco Gonzalez M, Saygili F, Pukitis A, Gaujoux S, Charnley RM, Lyadov V. Influence of cachexia and sarcopenia on survival in pancreatic ductal adenocarcinoma: a systematic review. Pancreatology. 2015 Jan-Feb;15(1):19-24. doi: 10.1016/j.pan.2014.11.006. Epub 2014 Dec 4.

  PMID: 25524484 BACKGROUND

• Dewys WD, Begg C, Lavin PT, Band PR, Bennett JM, Bertino JR, Cohen MH, Douglass HO Jr, Engstrom PF, Ezdinli EZ, Horton J, Johnson GJ, Moertel CG, Oken MM, Perlia C, Rosenbaum C, Silverstein MN, Skeel RT, Sponzo RW, Tormey DC. Prognostic effect of weight loss prior to chemotherapy in cancer patients. Eastern Cooperative Oncology Group. Am J Med. 1980 Oct;69(4):491-7. doi: 10.1016/s0149-2918(05)80001-3.

  PMID: 7424938 BACKGROUND

• Aoyagi T, Terracina KP, Raza A, Matsubara H, Takabe K. Cancer cachexia, mechanism and treatment. World J Gastrointest Oncol. 2015 Apr 15;7(4):17-29. doi: 10.4251/wjgo.v7.i4.17.

  PMID: 25897346 BACKGROUND

• Tazi E, Errihani H. Treatment of cachexia in oncology. Indian J Palliat Care. 2010 Sep;16(3):129-37. doi: 10.4103/0973-1075.73644.

  PMID: 21218002 BACKGROUND

• Fearon KC, Voss AC, Hustead DS; Cancer Cachexia Study Group. Definition of cancer cachexia: effect of weight loss, reduced food intake, and systemic inflammation on functional status and prognosis. Am J Clin Nutr. 2006 Jun;83(6):1345-50. doi: 10.1093/ajcn/83.6.1345.

  PMID: 16762946 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Inflammation; Cachexia

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Thinness

Study Officials

• Angel Lanas Arbeloa, MD, PhD

  University Hospital Lozano Blesa. IIS Aragón. CIBER de Enfermedades Hepáticas y Digestivas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The statistician responsible for analysing the data was also blinded. Only the nurse in charge of recruiting participants and releasing the products was non-blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Digestive Service (University Clinic Hospital Lozano Blesa) and Principal Investigator

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: June 23, 2026
• Study Start: March 4, 2019
• Primary Completion: September 17, 2023
• Study Completion: June 20, 2025
• Last Updated: June 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)