Trial reportPloS one2025
Effect of immunonutrition during concurrent chemoradiotherapy on acute oral mucositis in head and neck cancer patients: A prospective randomized study.
Trial report in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Guidelines for nutrition in adults with head and neck cancer: The American Society for Parenteral and Enteral Nutrition.JPEN. Journal of parenteral and enteral nutrition · 2026Guideline
- Perioperative Immunonutrition and Postoperative Recovery Patterns in Oral Squamous Cell Carcinoma Surgery: A Prospective Observational Cohort Study.Journal of nutrition and metabolism · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveImmunonutrition (IN) supplements, designed to modulate immune system, may help reduce treatment-related toxicities. This study aimed to evaluate the efficacy of IN in reducing acute oral mucositis (OM) and other side effects in head and neck cancer patients undergoing concurrent chemoradiotherapy (CCRT).
methodsA multicenter, prospective, open-label randomized controlled study was conducted to assess the impact of IN on reducing OM and other side effects in head and neck cancer patients undergoing CCRT. Patients were randomized into either IN or control arms. Those in the IN arm received IN sachets starting one week before radiotherapy until treatment completion, while the control arm received no supplement. Treatment outcomes were evaluated using Common Terminology Criteria for Adverse Events (CTCAE) version 5 and patient-reported outcomes via National Cancer Institute's Patient-Reported Outcomes of CTCAE (NCI-PRO-CTCAE). Mixed-effects logistic regression was performed to analyze outcomes between the groups, adjusting for chemotherapy regimens, while Chi-squared tests were used for group comparisons at specific timepoints.
resultsA total of 87 patients were analyzed with 46 in IN arm and 41 in control arm. Physician evaluations showed similar rates of grade 2 or higher OM, dermatitis, esophagitis, and hematologic toxicities across both arms. Patient-reported outcomes also showed no significant differences in the severity of oral mucositis or its interference with daily activities. A significant reduction of dermatitis was observed at week 3 in the IN arm (9.8% vs. 34.8%, p = 0.03), but this effect was not sustained in later weeks.
conclusionIN supplementation during CCRT did not result in statistically significant reductions in acute oral mucositis and other radiation toxicities. Further research with larger sample sizes, compliance monitoring, and optimized supplementation protocols is warranted to better understand the potential benefits of IN.
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Registered trials
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