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Photobiomodulation therapy (PBMT) has increasingly been used to manage oral toxicities secondary to cancer treatment; however, its impact on the stimulation of malignant cells is currently unknown. This 4-arm, double-blind, phase III randomized controlled clinical trial (RBR-4w4wwx) was designed to assess the impact of prophylactic PBMT for oral and oropharyngeal mucositis (OM) in the survival rates of patients with oral and oropharyngeal squamous cell carcinoma (OPSCC). Patients were randomly allocated to 4 groups: intraoral prophylactic PBMT (G1), placebo intraoral PBMT (G2), extraoral prophylactic PBMT (G3), and placebo extraoral PBMT (G4). OM grade (NCI) and OM-associated pain (EVA scale) were assessed weekly during OPSCC treatment. Tumor outcomes were evaluated quarterly during 12 months. Data analysis was performed using descriptive statistics. A total of 45 OPSCC patients were included. OM peak ulcerations (grade 2 or higher) were observed at week 3 for G1, G2, and G4 and at week 5 for G3. Placebo groups had the highest levels of pain when compared with the treatment/intervention groups (P <.05). No evidence of oral premalignant lesions or second primary tumors were observed in any of the patients included. In terms of cancer treatment outcomes, tumor persistence and regional metastases were higher among placebo patients after 12 months of follow-up (P <.05). Death due to disease progression was observed in 25% of patients from the treatment/intervention groups and 37.5% of placebo patients (P <.05). No negative impact of prophylactic PBMT for OM could be detected in terms OPSCC treatment outcomes. [ABSTRACT FROM AUTHOR]

Photobiomodulation therapy (PBMT) is recommended for the prevention of radiation-induced oral mucositis (OM) in head and neck patients. It is unclear to what extent the delivered PBMT therapy effectively provides an adequate uniform dose to the at-risk tissues. To characterize oral sites affected by radiation-induced OM and its clinicopathologic outcomes in oral squamous cell carcinoma (OSCC) patients subjected to prophylactic PBMT. The site distribution of OM, OM grading (NCI, Version 4.0), OM-related pain (visual analog scale), analgesic protocol (WHO), and use of enteral nutrition were evaluated weekly during treatment for OSCC patients with prophylactic PBMT. Data analysis was performed using descriptive statistics. One hundred forty-five OSCC patients were included. The most frequently affected sites by OM included lateral tongue (44.1%) and buccal mucosa (37.2%). Keratinized oral mucosae sites, including the tongue dorsum (6.21%) and retromolar trigone (8.3%), were also affected. Peak OM scores were observed at weeks 5, 6 and 7, with severe OM (NCI grades 3 and 4) rates of 11%, 20%, and 25%, respectively. The cumulative occurrence of severe OM was 23%, which developed as early as week 3 and as late as week 7. The highest mean value of OM-related pain (2.7) was observed in the sixth week, and 13.8% of the patients required feeding support. Compared to previously published studies that did not provide PBMT, OM, pain and analgesia and tube feeding use reduction was seen. Keratinized surfaces should also be included in the prophylactic PBMT for OM aiming to reduce severe OM. [ABSTRACT FROM AUTHOR]