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NCT05242991
Effectiveness of Photobiomodulation Protocols in Radiation-induced Oral Side Effects in H&N Cancer Patients
NA trial testing Photobiomodulation therapy in Mucositis in 132 participants. Status unknown.
1 March 2023
Quick facts
| Lead sponsor | Federal University of Rio Grande do Sul |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 132 |
| Start date | 1 March 2021 |
| Primary completion | 1 March 2023 |
| Estimated completion | 1 October 2024 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- Photobiomodulation therapy
Conditions studied
- Mucositis — all drugs for Mucositis →
- Xerostomia — all drugs for Xerostomia →
- Hyposalivation — all drugs for Hyposalivation →
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):
-
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 -
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:
- PubMed search for NCT05242991
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT04036994 — PBMT for the Management of CIA ( HAIRLASER ) · NA · unknown
Other recruiting trials for Mucositis
Currently open trials in the same condition.
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Other Federal University of Rio Grande do Sul trials
Trials by the same sponsor.
- NCT06967493 — Effects of Amazonian Dance on Motor and Non-motor Symptoms of People With Parkinson's: Study Protocol · NA · recruiting
- NCT07470450 — Acute and Chronic Effects of Combined Training on BP in Hypertensives · NA · completed
- NCT07023146 — Effects of Different Power Training Intensities in Older Adults · NA · enrolling by invitation
- NCT06912269 — Effects of Strength Training on the Plantar Flexors' Properties After Achilles Tendon Rupture · NA · recruiting
- NCT06416046 — Efficacy of Photobiomodulation in the Treatment and Relief of Pain in Recurrent Aphthous Stomatitis · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05242991 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Federal University of Rio Grande do Sul
- Last refreshed: 9 March 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05242991.
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