Evidence map›Paper›PMID 41984990›Full record

ArticlePloS one2026

Nutritional prehabilitation in head and neck cancer patients (PreHead) - A randomized controlled trial study protocol.

D Sijbrands, D Gort-van Dijk, S A H J de Visscher, A van der Hoorn, R J H M Steenbakkers, H Jager-Wittenaar, G H de Bock, A T Zwart, G B Halmos, I Wegner

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in PloS one, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

10 authors.

D SijbrandsDepartment of Otorhinolaryngology and Head and Neck Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.ORCID https://orcid.org/0009-0009-3181-1432
D Gort-van DijkDepartment of Nutrition and Dietetics, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
S A H J de VisscherDepartment of Oral and Maxillofacial surgery and Head and Neck Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
A van der HoornDepartment of Radiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.ORCID https://orcid.org/0000-0003-4649-327X
R J H M SteenbakkersDepartment of Radiation Oncology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
H Jager-WittenaarResearch Group Healthy Ageing, Allied Health Care and Nursing, Hanze University of Applied Sciences, Groningen, The Netherlands.
G H de BockDepartment of Epidemiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.ORCID https://orcid.org/0000-0003-3104-4471
A T ZwartDepartment of Radiation Oncology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
G B HalmosDepartment of Otorhinolaryngology and Head and Neck Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.ORCID https://orcid.org/0000-0003-2460-2260
I WegnerDepartment of Otorhinolaryngology and Head and Neck Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.ORCID https://orcid.org/0000-0002-4124-7224

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

rationaleUp to 60% of patients with head and neck cancer are malnourished upon first presentation. Malnutrition has been associated with a higher risk of adverse events and decreased quality of life and survival. Patients with a high risk of malnutrition often receive pretreatment dietary treatment before surgery or (chemo)radiotherapy, i.e., nutritional prehabilitation. However, previous research suggests that patients with a low or medium risk of malnutrition may also benefit from nutritional prehabilitation.

objectiveTo investigate the effect of nutritional prehabilitation on adverse events, nutritional status, patient-reported quality of life, tumor recurrence, and (disease-specific and overall) survival. To evaluate the cost-effectiveness of nutritional prehabilitation compared with standard care. STUDY

designA single-center, non-blinded, randomized controlled trial. STUDY POPULATION: Patients with locoregionally advanced stage (III or IV) primary mucosal squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx treated with curative intent and with a low or medium risk of malnutrition according to the Malnutrition Universal Screening tool. SAMPLE SIZE: Based on a power analysis, a total of 128 patients will be included.

interventionThe intervention arm will receive nutritional prehabilitation and the control arm will receive standard care (no nutritional prehabilitation). MAIN STUDY PARAMETERS/ENDPOINTS: Adverse events (i.e., surgical complications and (chemo)radiotherapy toxicity). Complications will be measured within 30 days after surgery using the Clavien-Dindo classification. Toxicity will be evaluated using the Common Terminology Criteria for Adverse Events (CTCAE), 6 and 12 weeks after the start of (chemo)radiotherapy. SIGNIFICANCE: It is hypothesized that nutritional prehabilitation, compared with no nutritional prehabilitation, will result in fewer (severe) adverse events, improvement of nutritional status, higher quality of life, equal risk of recurrence and better survival. It is hypothesized that the intervention will be cost-effective.

trial registrationThe trial is registered in the Dutch Trial Register under registration number NL87676.042.24.

Indexed as

Carcinoma, Squamous CellHead and Neck NeoplasmsMalnutritionPreoperative CareCost-Benefit AnalysisFemaleHumansMaleNutritional StatusQuality of LifeRandomized Controlled Trials as Topic

Identifiers

PMID41984990
PMCPMC13082693

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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.