Trial reportNutrition journal2025
Nutritional impact of eicosapentaenoic acid supplementation (EPA) in patients with locally advanced head and neck cancer: a double-blind placebo-controlled randomized trial.
Trial report in Nutrition journal, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02715596 (Relationship Between Changes in Body Composition and Supplementation With EPA in Patients Diagnosed With Squamous Cell Carcinoma of Head and Neck Locally Advanced), which is not on this map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Relationship Between Changes in Body Composition and Supplementation With EPA in Patients Diagnosed With Squamous Cell Carcinoma of Head and Neck Locally Advanced (Stage III-IVb)
Who cites it
0 citing papers in PubMed.
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Corrections and comments
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Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundEvidence on the benefits of eicosapentaenoic acid (EPA) supplementation in cancer patients remains inconsistent, likely due to heterogeneity in tumor types, stages, treatment modalities, and nutritional strategies. This study aimed to assess the impact of EPA as a standalone supplement on body weight, body mass index (BMI), and muscle mass preservation in patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) undergoing curative-intent treatment.
methodsWe conducted a double-blind, placebo-controlled randomized trial between December 2015 and September 2018, enrolling 54 patients with advanced SCCHN. Participants received either 2.7 g/day of oral EPA or placebo, alongside standard nutritional support according to European Society for Clinical Nutrition and Metabolism (ESPEN) guidelines. Assessments were performed at baseline (T0), post-induction chemotherapy (T1), and post-treatment (T2), including body composition, nutritional status, functionality, and inflammatory biomarkers. Plasma EPA (% of total fatty acids) was used as a biochemical marker of compliance.
resultsBoth groups were balanced at baseline (median age 58.9 years; 46.3% malnourished). Neither the intention-to-treat nor per-protocol analyses showed statistically significant differences between groups in weight loss, BMI, or body composition (p > 0.05). In the per-protocol analysis, estimated mean weight loss was –3.81 kg (95% CI: –5.70 to –1.91) in the EPA group, compared to –7.72 kg (95% CI: –12.8 to –6.40) in the placebo group. No differences were observed in nutritional status, energy or protein intake, physical function, or treatment-related toxicity. Complete response rates after oncological treatment were comparable (77.8% EPA vs. 66.7% placebo). Only half of the patients in the EPA group reached an increase in plasma EPA levels consistent with supplementation, and 31.5% discontinued the intervention due to intolerance.
conclusionsOur study did not demonstrate a clear benefit of EPA supplementation on weight, BMI, or muscle preservation in patients with locally advanced SCCHN receiving curative-intent treatment. While EPA was safe and feasible, the findings do not provide sufficient evidence to support a clinically significant effect. Further research with larger sample sizes and more robust designs is warranted to better understand the potential role of EPA in this population.
trial registrationClinicalTrials.gov identifier: NCT02715596 (registered on March 22, 2016 at ClinicalTrials.gov).
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