Abstract
PurposeTo assess the safety and efficacy of prophylactic extraoral photobiomodulation (PBM) for the prevention of oral and oropharyngeal mucositis (OM) on clinical outcomes and survival in patients with oral cavity and oropharyngeal squamous cell carcinoma (OOPSCC).MethodsOOPSCC patients who received radiotherapy (RT) were prospectively randomized to two groups: prophylactic extraoral PBM and placebo. OM grade (NCI), pain (VAS), analgesia, and anti-inflammatory prescriptions were assessed weekly. Quality of life questionnaires (QoL) were performed at the first and last day of RT. Following RT, participants were evaluated quarterly for oncological outcomes follow-up.ResultsFifty-five patients met the inclusion criteria. The first occurrence of OM was observed at week 1, for the placebo group (p = 0.014). Later, OM onset and severity was observed for the PBM group, with first occurrence at week 2 (p = 0.009). No difference in severe OM incidence was observed (p > 0.05). Lower mean pain score was noted at week 7 for the PBM group (2.1) compared to placebo group (4.5) (p = 0.009). Less analgesics (week 3; p = 0.009/week 7; p = 0.02) and anti-inflammatory prescription (week 5; p = 0.0346) were observed for the PBM group. Better QoL scores were observed for the PBM group at last day of RT (p = 0.0034). No difference in overall survival among groups was observed in 1 year of follow-up (p = 0.889).ConclusionProphylactic extraoral PBM can delay OM onset, reduce pain, and reduce analgesic and anti-inflammatory prescription requirements. Extraoral PBM was associated with better QoL. There was no evidence of PBM impact on oncological outcomes.Trial registrationTRN:RBR-4w4swx (date of registration: 01/20/2020).Supplementary InformationThe online version contains supplementary material available at 10.1007/s00520-021-06625-8.
Highlights
Oral mucositis (OM) is an acute side effect of the cytotoxic cancer treatment that is severe in head and neck cancer (HNC) patients undergoing radiotherapy (RT) and chemoradiotherapy (CRT)
We present the results of a planned interim analysis when at least 55 participants had completed a minimum of 1 year of follow-up
We evaluated the effects of a prophylactic extraoral PBM in the outcomes of RT-induced OM and oncological outcomes
Summary
Oral mucositis (OM) is an acute side effect of the cytotoxic cancer treatment that is severe in head and neck cancer (HNC) patients undergoing radiotherapy (RT) and chemoradiotherapy (CRT). Extended author information available on the last page of the article and dysfunction distress due to pain with impairment in eating, swallowing, and speech functions [36, 42] This morbidity has marked negative impact on patient’s quality of life (QoL); increases treatment costs due to the need of hospitalization, nutritional support, opioids use, antimicrobials and anti-inflammatory drugs; and may lead to new or prolonged hospitalization [24]. PBM is well established and accessible, there is great variability in PBM parameters, protocols, and equipment, which hampers consistent evaluation [7, 19] Another challenge to the large acceptance of PBM relies on the possibility that it may stimulate the growth of residual tumor cells or impact the field of cancerization in HNC [8, 17, 21, 37]. It is paramount that interventions used to mitigate OM do so without negatively impacting the effectiveness of the tumor treatment, especially in cases where the PBM application is anatomically adjacent to the tumor field, such as in HNC [39]
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