Evidence map›Paper›PMID 38239654›Full record

ArticleFrontiers in oncology2023

Dietary intervention for tertiary prevention in head and neck squamous cell carcinoma survivors: clinical and translational results of a randomized phase II trial.

Stefano Cavalieri, Eleonora Bruno, Mara Serena Serafini, Deborah Lenoci, Silvana Canevari, Laura Lopez-Perez, Liss Hernandez, Luigi Mariani, Rosalba Miceli, Cecilia Gavazzi and 10 more

Open access · goldAbstract read
In one paragraph

Article in Frontiers in oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact, top 100% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 0 citations in OpenAlex.

  1. Risk of employment separation among workers with head and neck cancer: a longitudinal cohort study in Turin.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors at 8 institutions in 6 countries.

Stefano Cavalieri *Head and Neck Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Eleonora Bruno *Nutrition Research and Metabolomics, Department of Experimental Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Mara Serena SerafiniIntegrated Biology of Rare Tumors Unit, Department of Research, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Deborah LenociIntegrated Biology of Rare Tumors Unit, Department of Research, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Silvana CanevariRetired, Milan, Italy.
Laura Lopez-PerezUniversidad Politecnica de Madrid-Life Supporting Technologies Research Group, ETSIT, Madrid, Spain.
Liss HernandezUniversidad Politecnica de Madrid-Life Supporting Technologies Research Group, ETSIT, Madrid, Spain.
Luigi MarianiBiostatistics for Clinical Research Unit, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.
Rosalba MiceliBiostatistics for Clinical Research Unit, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.
Cecilia GavazziClinical Nutrition Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Patrizia PasanisiNutrition Research and Metabolomics, Department of Experimental Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Elena RossoHead and Neck Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Francesca CorderoDepartment of Computer Science, University of Torino, Torino, Italy.
Paolo BossiHead and Neck Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Wojciech GolusinskiDepartment of Head and Neck Surgery, Poznan University of Medical Sciences, Poznan, Poland.
Andreas DietzDepartment of Otolaryngology, Head and Neck Surgery, Universitätsklinikum, Leipzig, Germany.
Primož StrojanDepartment of Radiation Oncology, Institute of Oncology Ljubljana, Ljubljana, Slovenia.
Thorsten FuerederDepartment of Medicine I, Medical University of Vienna, Vienna, Austria.
Loris De CeccoIntegrated Biology of Rare Tumors Unit, Department of Research, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Lisa LicitraHead and Neck Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Fondazione IRCCS Istituto Nazionale dei Tumori · ITUniversidad Politécnica de Madrid · ESUniversity of Milan · ITInstitute of Oncology Ljubljana · SIMedical University of Vienna · ATPoznan University of Medical Sciences · PLUniversity Hospital Leipzig · DEUniversity of Turin · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: There is a strong need for preventive approaches to reduce the incidence of recurrence, second cancers, and late toxicities in head and neck squamous cell carcinoma (HNSCC) survivors. We conducted a randomized controlled trial (RCT) to assess a dietary intervention as a non-expensive and non-toxic method of tertiary prevention in HNSCC survivors. Methods: Eligible participants were disease-free patients with HNSCC in follow-up after curative treatments. Subjects were randomized 1:1 to receive a highly monitored dietary intervention plus the Word Cancer Research Fund/American Institute for Cancer Research recommendations for cancer prevention (intervention arm) or standard-of-care recommendations (control arm). The planned sample size for the event-free survival evaluation (primary endpoint) was not reached, and the protocol was amended in order to investigate the clinical (nutritional and quality-of-life questionnaires) and translational study [plasma-circulating food-related microRNAs (miRNAs)] as main endpoints, the results of which are reported herein. Results: One hundred patients were screened, 94 were randomized, and 89 were eligible for intention-to-treat analysis. Median event-free survival was not reached in both arms. After 18 months, nutritional questionnaires showed a significant increase in Recommended Food Score (p = 0.04) in the intervention arm vs. control arm. The frequency of patients with and without a clinically meaningful deterioration or improvement of the C30 global health status in the two study arms was similar. Food-derived circulating miRNAs were identified in plasma samples at baseline, with a significant difference among countries. Conclusion: This RCT represented the first proof-of-principle study, indicating the feasibility of a clinical study based on nutritional and lifestyle interventions in HNSCC survivors. Subjects receiving specific counseling increased the consumption of the recommended foods, but no relevant changes in quality of life were recorded between the two study arms. Food-derived plasma miRNA might be considered promising circulating dietary biomarkers.

Indexed as

cancer survivorsdiet habitsfood-derived miRNAshead and neck cancerquestionnairestertiary cancer preventiontranslational research

Identifiers

PMID38239654
PMCPMC10794719
OpenAlexW4390584289

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.