Human research · RCT
Freitas IOP et al., Supportive Care in Cancer 2026
In a single-centre, randomised trial in Brazil of children and teens (1-18 years) receiving high-dose methotrexate (HDMTX) chemotherapy, preventive photobiomodulation (PBM, low-level red laser) applied from outside the face (extraoral, about 30 s per session) and inside the mouth (intraoral, about 6 min per session) were followed by oral mucositis in 30.5% vs 41.1% of children, a difference that was not statistically significant. The trial had no untreated control group and was designed and powered to detect a difference, not to prove equivalence, so it does not show that the two methods are equally effective or that PBM itself prevented mucositis; it was also not prospectively registered.
Source: Comparable efficacy of extraoral and intraoral photobiomodulation in preventing oral mucositis during high-dose methotrexate therapy in pediatric oncology: A single-blind randomized controlled trial. Freitas IOP, Schuartz I, Renz GLK, Mobile RZ, França MLS, Pianovski MAD, Sassi LM, de Araujo MR. Supportive Care in Cancer. 2026. doi:10.1007/s00520-026-11372-9. PMID:42897331. Published 2026-10-19 (open access). Ethics: CAAE 52808121.1.0000.0098. Registration: none (not prospectively registered, per authors)
Verified research card EL-20261020-01-R1