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NCT05242991

Effectiveness of Photobiomodulation Protocols in Radiation-induced Oral Side Effects in H&N Cancer Patients

Status unknown NA Last updated 9 March 2023
What this trial tests

NA trial testing Photobiomodulation therapy in Mucositis in 132 participants. Status unknown.

Timeline
1 March 2021
Primary endpoint
1 March 2023
1 October 2024

Quick facts

Lead sponsorFederal University of Rio Grande do Sul
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeprevention
Enrollment132
Start date1 March 2021
Primary completion1 March 2023
Estimated completion1 October 2024
Sites1 location across Brazil

Drugs / interventions tested

Conditions studied

Sponsor

Federal University of Rio Grande do Sul

Who can join

Adults 18 to 90, any sex, with Mucositis or Xerostomia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Head and neck cancer (HNC) are among the most frequent malignancies in the world. The main treatment modalities for HNC are surgical excision, radiotherapy (RT), and chemotherapy (CT). Severe oral sequelae such as oral mucositis (OM), dysgeusia, opportunistic infections, trismus, and xerostomia/hyposalivation can affect HNC patients due to oncological treatment with RT and QT. Photobiomodulation therapy (PBMT) with an intraoral low-power laser has been studied as an excellent tool in the management of OM and xerostomia and thus improves the tolerability of RT in the head and neck region. The aim of this multicenter, randomized, single-blind clinical trial is to compare the effects of two photobiomodulation protocols (intraoral application low-level laser and defocused extraoral application of high-power laser) in the management of oral mucositis (OM) and xerostomia in head and neck cancer patients undergoing radiotherapy (RT). It is expected defocused extraoral high-power photobiomodulation shows results as good as intraoral photobiomodulation on the management of oral mucositis.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Cancer treatment-related xerostomia: basics, therapeutics, and future perspectives.
    Hosseini MS, Sanaie S, Mahmoodpoor A, Jabbari Beyrami S, et al · · 2024 · cited 12× · PMID 39614391 · DOI 10.1186/s40001-024-02167-x
  2. Intraoral vs. extraoral photobiomodulation therapy for oral mucositis in head and neck cancer patients: a multicenter, randomized, single-blind clinical trial.
    Klein IP, Pinto MBR, Só BB, de Farias Gabriel A, et al · · 2025 · PMID 40928526 · DOI 10.1007/s00520-025-09877-w

Verify or expand the search:

Other trials of Photobiomodulation therapy

Trials testing the same drug.

Other recruiting trials for Mucositis

Currently open trials in the same condition.

Other Federal University of Rio Grande do Sul trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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