Evidence map›Paper›PMID 34527079›Full record

ArticleTherapeutic advances in medical oncology2021

The efficacy of immunonutrition in improving tolerance to chemoradiotherapy in patients with head and neck cancer, receiving nutritional counseling: study protocol of a randomized, open-label, parallel group, bicentric pilot study.

Riccardo Caccialanza, Emanuele Cereda, Catherine Klersy, Mariateresa Nardi, Sara Masi, Silvia Crotti, Silvia Cappello, Valentina Caissutti, Carlotta Brovia, Federica Lobascio and 15 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Therapeutic advances in medical oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04611113 (Efficacy of Immunonutrition in Improving Tolerance to Chemoradiotherapy in Patients With Head-neck Cancer), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.0field-weighted citation impact, top 26% 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.

NCT04611113 narecruitingnot on this map

Efficacy of Immunonutrition in Improving Tolerance to Chemoradiotherapy in Patients With Head-neck Cancer

TypeinterventionalSponsorFondazione IRCCS Policlinico San Matteo di PaviaRan2021 to 2026Enrolled86ConditionsHead and Neck CancerArmsImmunonutrition, Control Nutritional Support
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 13 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Review
  5. Mapping the global research landscape on nutritional support for patients with gastrointestinal malignancy: visualization analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023
    Review
  6. 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

25 authors at 4 institutions in 1 country.

Riccardo CaccialanzaClinical Nutrition and Dietetics Unit, Fondazione IRCCS Policlinico San Matteo, Viale Golgi 19, Pavia, 27100, Italy.ORCID https://orcid.org/0000-0002-9379-3569
Emanuele CeredaClinical Nutrition and Dietetics Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Catherine KlersyBiometry and Clinical Epidemiology Service, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Mariateresa NardiClinical Nutrition Service, Veneto Institute of Oncology-IRCCS, Padua, Italy.
Sara MasiClinical Nutrition and Dietetics Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Silvia CrottiClinical Nutrition and Dietetics Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Silvia CappelloClinical Nutrition and Dietetics Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Valentina CaissuttiClinical Nutrition and Dietetics Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.ORCID https://orcid.org/0000-0001-5245-2736
Carlotta BroviaClinical Nutrition and Dietetics Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.ORCID https://orcid.org/0000-0001-7092-1903
Federica LobascioClinical Nutrition and Dietetics Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Elena FormisanoClinical Nutrition and Dietetics Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Sara ColomboRadiation Oncology Department, Fondazione IRCCS Policlinico San Matteo and University of Pavia, Pavia, Italy.
Andrea Riccardo FilippiRadiation Oncology Department, Fondazione IRCCS Policlinico San Matteo and University of Pavia, Pavia, Italy.ORCID https://orcid.org/0000-0001-7159-7869
Elisabetta BonzanoRadiation Oncology Department, Fondazione IRCCS Policlinico San Matteo and University of Pavia, Pavia, Italy.
Patrizia ComoliCell Factory and Pediatric Hematology Oncology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Laura CatenacciCell Factory and Pediatric Hematology Oncology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Andrea AlbertiDepartment of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, ASST Spedali Civili, Brescia, Italy.
Valeria MusellaBiometry and Clinical Epidemiology Service, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Alessandra FerrariMedical Oncology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Ilaria ImarisioMedical Oncology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Richard TancrediMedical Oncology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Teresa MonacoMedical Oncology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Maria Grazia GhiOncology Unit 2, Istituto Oncologico Veneto-IRCCS, Padua, Italy.
Paolo BossiDepartment of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, ASST Spedali Civili, Brescia, Italy.
Paolo PedrazzoliMedical Oncology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Policlinico San Matteo Fondazione · ITUniversity of Pavia · ITIstituto Oncologico Veneto · ITUniversity of Brescia · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNutritional support, including nutritional counseling and oral nutritional supplements (ONSs), has been recommended at the earliest opportunity in head and neck (H&N) cancer patients. The limited available evidence on the efficacy of immunonutrition during chemoradiotherapy (CT-RT) in H&N cancer patients is positive with regard to some secondary endpoints, but is still scanty, particularly with regard to toxicity and treatment tolerance. We hypothesize that early systematic provision of ONSs with a high-protein-high-calorie mixture containing immunonutrients (Impact) compared to standard high-calorie-high-protein nutritional blends, in addition to nutritional counseling, may be beneficial to patients with H&N cancer during CT-RT. Hence, we designed the present study to evaluate the efficacy, in terms of treatment tolerance, toxicity and response, body weight, body composition, protein-calorie intake, quality of life (QoL), fatigue, muscle strength and immunological profile of the early systematic provision of ONSs enriched in immunonutrients compared to isonitrogenous standard blends, in H&N cancer patients undergoing CT-RT.

methodsThis is a pragmatic, bicentric, randomized (1:1), parallel-group, open label, controlled, pilot clinical trial. DISCUSSION: Many efforts are still to be taken to improve the efficacy of nutritional support in oncology. Immunonutrition represents a promising approach also in H&N cancer patients, but the evidence on its efficacy in improving clinical outcomes during CT-RT is still inconclusive. The present pilot study, which guarantees the early provision of nutritional assessment and support to all the enrolled patients in accordance with the recent guidelines and recommendations, could represent one of the first proofs of the clinical effectiveness of early oral immunonutrition in cancer patients undergoing CT-RT and could stimulate further large randomized trials, potentially resulting in the improvement of supportive care quality.

trial registrationThis study is registered on ClinicalTrials.gov Identifier: NCT04611113.

Indexed as

chemoradiotherapyhead and neck cancerimmunonutritionmalnutritionnutritional counselingtreatment tolerance

Identifiers

PMID34527079
PMCPMC8436314
OpenAlexW3199366737

What OpenQuestion holds

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Registered trials

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.