Evidence map›Paper›PMID 41013422›Full record

Trial reportBMC oral health2025

Photobiomodulation for restoring salivary flow after radiotherapy in head and neck cancer: a randomised placebo-controlled trial.

Maria Lopez-Garzon, Maria Del Carmen Plata-Peregrina, Ena Isabel Perez-Sanchez, Mario Lozano-Lozano, Francisco Artacho-Cordon, Noelia Galiano-Castillo

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC oral health, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05614843 (Pilot Study Evaluating the Impact of a Photobiomodulation Therapy on Xerostomia and Hyposalivation in Patients With Head and Neck Cancer Post-Radiotherapy), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–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.

NCT05614843 nacompletednot on this map

Pilot Study Evaluating the Impact of a Photobiomodulation Therapy on Xerostomia and Hyposalivation in Patients With Head and Neck Cancer Post-Radiotherapy

TypeinterventionalSponsorUniversidad de GranadaRan2022 to 2023Enrolled32ConditionsHead and Neck Cancer, Head and Neck Neoplasms, XerostomiaArmsEnergy density photobiomodulation (7.5), Sham placebo
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Review
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

6 authors.

Maria Lopez-GarzonBiomedical Group (BIO277), Department of Physical Therapy, Health Sciences Faculty, University of Granada, Granada, Spain.
Maria Del Carmen Plata-PeregrinaClínica Rocamar, Granada, Spain.
Ena Isabel Perez-SanchezDepartment of Radiation Oncology, Hospital Universitario de Jaén, Jaén, Spain.
Mario Lozano-LozanoBiomedical Group (BIO277), Department of Physical Therapy, Health Sciences Faculty, University of Granada, Granada, Spain. mlozano@ugr.es.
Francisco Artacho-CordonInstituto de Investigación Biosanitaria ibs.GRANADA, Granada, Spain.
Noelia Galiano-CastilloBiomedical Group (BIO277), Department of Physical Therapy, Health Sciences Faculty, University of Granada, Granada, Spain.

Funding

Consejería de Salud y Consumo, Junta de Andalucía PI-0187-2021Universidad de Granada PPJIA2020-15
6 · The paper itself

Abstract

backgroundHead and neck cancer (HNC) treatment modalities, especially radiotherapy (RT), often lead to salivary gland dysfunction, resulting in hyposalivation and xerostomia, which impair patients' quality of life. Photobiomodulation (PBM) therapy, a noninvasive approach using nonthermal red/near-infrared light, has shown promise in mitigating these side effects. This study evaluated the impact of PBM therapy on salivary flow, biochemical biomarkers, patient-reported outcome measures and mouth opening in patients with HNC suffering from chronic xerostomia after RT.

methodsIn a prospective, two-arm, randomised, placebo-controlled, double-blinded trial, 31 adult patients with HNC in complete remission and chronic xerostomia (> 3 months after RT) were enrolled. Participants were randomised (1:1) to receive either active PBM therapy or a sham intervention. The PBM protocol employs an 830 nm diode device applied intra- and extraorally over 24 sessions (twice weekly for 3 months) targeting the major salivary glands. The outcome measures assessed at baseline, 3 months (postintervention), and 6 months included the unstimulated salivary flow rate (SFR) by sialometry, total protein and IgA (sialochemistry), quality of life via European Organisation for Research and Treatment of Cancer (EORTC) questionnaires, severity of xerostomia, dysphagia, and mouth opening. Data were analysed using repeated measures analysis of covariance (ANCOVA) (adjusting for relevant covariates) and nonparametric tests, as appropriate.

resultsCompared with the placebo group, the PBM group presented a nearly significant increase in the SFR (0.22 ± 0.29 vs. 0.05 ± 0.15 ml/min, p = 0.051; effect size d = 0.75) after the intervention. A responder analysis revealed that five patients in the PBM group shifted from hyposalivation (SFR < 0.25 ml/min) to normal salivary flow, whereas no such change was observed in the placebo group (p = 0.048). Both groups reported similar levels of satisfaction and adherence, and no adverse events were recorded.

conclusionsPBM therapy demonstrated potential benefits in improving salivary flow among oncological patients with chronic RT-induced xerostomia, suggesting possible regenerative effects on the salivary glands. Despite the objective improvements in the SFR, changes in biochemical markers and the remaining outcome measures were less definitive in patients with HNC. Further studies with larger sample sizes are needed to confirm these preliminary findings and better delineate the clinical utility of this therapy.

trial registrationThis trial was registered on ClinicalTrials.gov (NCT05614843) and First Posted date [2022-11-14].

Indexed as

Head and Neck NeoplasmsLow-Level Light TherapyXerostomiaAdultAgedDouble-Blind MethodFemaleHumansMaleMiddle AgedProspective StudiesQuality of LifeSalivaSalivary GlandsHead and neck neoplasmsLow-level light therapyQuality of lifeXerostomia

Identifiers

PMID41013422
PMCPMC12465775

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.