Evidence map›Paper›PMID 42360517›Full record

Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2026

Randomized, double-blind, sham-controlled trial of an intraoral photobiomodulation device for oral mucositis and associated complications due to radiotherapy for head and neck cancer.

Kenneth Hu, Pratish Shah, M Connie Nguyen, Cornelia McCluskey, Anne Kane, Roger Ove, Christopher D Willey, Sanford Katz, Omkar Marathe, Sasha Valentin and 6 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03972527 (Photobiomodulation Therapy Using the MuReva Phototherapy System to Demonstrate Safety and Reduce the Incidence of Oral Mucositis in Adult Patients With Head and Neck Cancer Receiving Radiation Therapy With or Without Concurrent Chemotherapy), which is not on this 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
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.

NCT03972527 nacompletednot on this map

Photobiomodulation Therapy Using the MuReva Phototherapy System to Demonstrate Safety and Reduce the Incidence of Oral Mucositis in Adult Patients With Head and Neck Cancer Receiving Radiation Therapy With or Without Concurrent Chemotherapy

TypeinterventionalSponsorMuReva Phototherapy Inc.Ran2022 to 2024Enrolled85ConditionsOral Mucositis (Ulcerative), Oral Mucositis (Ulcerative) Due to Radiation, Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy, Head and Neck CancerArmsPhotobiomodulation, Routine Oral Care and Analgesia
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

16 authors.

Kenneth HuDepartment of Radiation Oncology and Department of Otolaryngology-Head and Neck Surgery, New York University, New York, NY, USA. kenneth.hu@nyulangone.org.ORCID https://orcid.org/0000-0003-4617-739X
Pratish ShahSt. Elizabeth Healthcare, Edgewood, KY, USA.
M Connie NguyenOklahoma Cancer Specialists and Research Institute, Tulsa, OK, USA.
Cornelia McCluskeyChrist Hospital, Cincinnati, OH, USA.
Anne KaneUniversity of Mississippi Medical Center, Jackson, MS, USA.
Roger OveMetroHealth, Case Western Reserve University, Cleveland, OH, USA.
Christopher D WilleyUniversity of Alabama at Birmingham, Birmingham, AL, USA.
Sanford KatzWillis-Knighton Cancer Center, Shreveport, LA, USA.
Omkar MaratheThe Oncology Institute of Hope and Innovation, Long Beach, CA, USA.
Sasha ValentinThe Ohio State University, Columbus, OH, USA.
Jennifer FrustinoErie County Medical Center, Buffalo, NY, USA.
Alessandro VillaMiami Cancer Institute, Miami, FL, USA.
Sharon SpencerUniversity of Alabama at Birmingham, Birmingham, AL, USA.
Catherine HoltzapfelSt. Elizabeth Healthcare, Edgewood, KY, USA.
Nathaniel TreisterBrigham and Women's Hospital, Boston, MA, USA.
Rajesh V LallaUniversity of Connecticut Health, Farmington, CT, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis study evaluated the safety and effectiveness of an intraoral light-emitting diode (LED)-based photobiomodulation (PBM) device to reduce the incidence and severity of oral mucositis (OM) from intensity modulated radiation therapy (IMRT) for head and neck cancer (HNC).

methodsThis randomized, double-blind, sham-controlled trial enrolled patients with HNC undergoing high-dose IMRT over 6-8 weeks, with or without concurrent chemotherapy. Participants received daily 10-min PBM or sham treatments immediately before IMRT sessions. Assessments were conducted at baseline, daily and weekly during IMRT, and two weeks post-IMRT.

resultsEighty-five participants (42 PBM; 43 sham) were enrolled across 12 US sites. No device-related adverse events were observed, and 99.5% of initiated sessions were completed. In the intent-to-treat population, severe OM (WHO Grade ≥ 3) incidence was significantly lower with PBM across six weeks of IMRT (36.8% vs 57.1%; p = 0.046) and at two weeks post-treatment (10.8% vs 36.4%; p = 0.042). In the per-protocol population, the PBM arm reported significantly greater taste preservation (p = 0.034), lower increases in mouth/throat soreness (p = 0.029) and throat pain (p = 0.028) and needed fewer feeding tube placements (p = 0.073) than the control arm.

conclusionDaily intraoral PBM therapy using an LED-based device was safe, well tolerated, and significantly reduced the incidence of severe OM and associated complications in HNC patients undergoing IMRT with or without concurrent chemotherapy. These findings align with guidelines recommending daily intraoral PBM therapy for preventing cancer therapy-related OM, a dose-limiting toxicity for which effective preventive interventions are needed.

trial registrationClinical Trials.gov Registration Number NCT03972527. Registered on June 3, 2019. Daily intraoral PBM therapy using an LED-based device was safe, well tolerated, and significantly reduced the incidence of severe OM and associated complications in HNC patients undergoing IMRT with or without concurrent chemotherapy. These findings align with guidelines recommending daily intraoral PBM therapy for preventing cancer therapy-related OM, a dose-limiting toxicity for which effective preventive interventions are needed.

Indexed as

Head and Neck NeoplasmsLow-Level Light TherapyRadiation InjuriesRadiotherapy, Intensity-ModulatedStomatitisAdultAgedDouble-Blind MethodFemaleHumansIncidenceMaleMiddle AgedSeverity of Illness IndexHead and neck cancerOral mucositisPhotobiomodulationRadiotherapy

Identifiers

PMID42360517

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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.