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Effects of EPA Supplementation on Patients With Unresectable Hepatocellular Carcinoma.

17. juni 2026 opdateret af: Ángel Lanas Arbeloa, Instituto de Investigación Sanitaria Aragón

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.

Dietary intervention with eicosapentaenoic acid combined with chemotherapy may shift inflammatory mediators toward resolution in non-resectable hepatocarcinoma and help to preserve muscle mass.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Cancer-associated cachexia is a debilitating and potentially life-threatening syndrome characterized by progressive loss of body weight, skeletal muscle, and adipose tissue, leading to functional impairment and reduced response to oncologic therapy. It is driven in part by systemic inflammation and increased pro-inflammatory cytokines, and it cannot always be reversed with conventional support.

Eicosapentaenoic acid (EPA), an omega-3 polyunsaturated fatty acid (PUFA), has anti-inflammatory properties and is rapidly incorporated into cell membranes, modulating lipid mediator pathways. EPA supplementation may help to attenuate systemic inflammation, alleviate cachexia symptoms, and promote the production of specialized pro-resolving mediators. A daily dose of 3 grams appears sufficient to achieve maximal incorporation into cell membranes without significant adverse events.

Hepatocellular carcinoma (HCC) is one of the leading causes of cancer-related mortality worldwide, with most patients diagnosed at advanced stages. Cachexia is common in advanced HCC and contributes to functional decline, increased treatment toxicity, and poorer outcomes. Preclinical studies suggest that omega-3 PUFAs may also exert anti-tumor effects through modulation of COX-2 and Wnt/beta-catenin signaling pathways.

For these reasons, in this proposal, the investigators aim to determine wheter supplementation with EPA in combination with chemotherapy will modify the blood profile of pro-inflammatory and pro-resolving mediators, promoting the resolution of inflammation associated with HCC, and, in turn, mitigate muscle mass loss during oncologic treatment.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

18

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Spanien
    • Zaragoza
      • Zaragoza, Zaragoza, Spanien, 50009
        • Hospital Clínico Universitario Lozano Blesa. IIS Aragón

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intervention group
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.
Kosttilskud: Eicosapentaenoic acid oral lipidic emulsion
1 sachet/day of 20 ml containing 3g EPA during 12 weeks
Placebo komparator: Control group
Patients with unresectable hepatocellular carcinoma (HCC) were given a placebo oral lipidic emulsion in addition to their oncologic care during 12 weeks.
Kosttilskud: Pacebo oral lipidic emulsion
1 sachet/day of 20 ml of placebo during 12 weeks

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Effect of EPA supplementation on muscle mass
Tidsramme: At baseline, and at 12 weeks (study completion)
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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Evolution of nutritional status.
Tidsramme: At baseline, at 6 weeks, and at 12 weeks (study completion)
Nutritional status is assessed using the validated Patient-Generated Subjective Global Assessment tool (PG-SGA, Bauer 2002) that classify patients as well nourished (A), moderately malnourished or at risk of malnutrition (B), or severely malnourished (C).
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.
Tidsramme: At baseline, at 6 weeks, and at 12 weeks (study completion)
Quality of life is assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (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.
Tidsramme: At baseline, at 6 weeks, and at 12 weeks (study completion)
Quality of life is assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Hepatocellular Carcinoma 18-question module (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.
Tidsramme: At baseline, and at 12 weeks (study completion)
Plasma and serum concentrations of pro-inflammatory and pro-resolving lipid mediators derived from polyunsaturated fatty acids are determined using targeted LC-MS/MS.
At baseline, and at 12 weeks (study completion)
Change in C-reactive protein (CRP) concentration upon supplementation.
Tidsramme: At baseline, and at 12 weeks (study completion)
The C-reactive protein is measured using an immunoturbidimetric assay following the standard laboratory methods in the Hospital Clínico Universitario Lozano Blesa.
At baseline, and at 12 weeks (study completion)
Change in interleukin 6 upon supplementation.
Tidsramme: At baseline, and at 12 weeks (study completion)
Plasma IL-6 levels are determined by enzyme-linked immunosorbent assay.
At baseline, and at 12 weeks (study completion)
Change in interleukin 8 upon supplementation.
Tidsramme: At baseline, and at 12 weeks (study completion)
Plasma Il-8 is quantified using the Human XL Cytokine Luminex® Kit Performance Assay (R&D Systems).
At baseline, and at 12 weeks (study completion)
Change in interferon gamma (IFNγ) upon supplementation.
Tidsramme: At baseline, and at 12 weeks (study completion)
Plasma IFNγ is quantified using the Human XL Cytokine Luminex® Kit Performance Assay (R&D Systems).
At baseline, and at 12 weeks (study completion)
Change in the neutrophil-to-lymphocyte ratio (NLR) upon supplementation.
Tidsramme: At baseline, and at 12 weeks (study completion)
NLR is calculated by dividing the absolute neutrophil count by the absolute lymphocyte count obtained from peripheral blood samples. Both values were derived from the complete blood count (CBC) analysis.
At baseline, and at 12 weeks (study completion)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Instituto de Investigación Sanitaria Aragón

Samarbejdspartnere

Solutex GC S.L.
Hospital Clínico Universitario Lozano Blesa

Efterforskere

  • Ledende efterforsker: Angel Lanas Arbeloa, MD, PhD, University Hospital Lozano Blesa. IIS Aragón. CIBER de Enfermedades Hepáticas y Digestivas

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

4. marts 2019

Primær færdiggørelse (Faktiske)

17. september 2023

Studieafslutning (Faktiske)

20. juni 2025

Datoer for studieregistrering

Først indsendt

8. maj 2026

Først indsendt, der opfyldte QC-kriterier

17. juni 2026

Først opslået (Faktiske)

23. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • LMP225_18

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Kliniske forsøg med Hepatocellulært karcinom

Kliniske forsøg med Eicosapentaenoic acid oral lipidic emulsion

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