Photobiomodulation Therapy With M-health Tool for the Management of Oral Health and Quality of Life in Head and Neck Cancer Patients: LAXER Study

What this Trial Is About

This research aims to evaluate the effects of Photobiomodulation (PBM) therapy combined with a mobile health application (LAXER) on oral health and quality of life in survivors of head and neck cancer who have undergone radiotherapy. The study focuses on determining the best dosages of PBM to treat radiotherapy-induced dry mouth (xerostomia) and whether the benefits can last after treatment ends, addressing the current lack of consensus on effective dosing. Participants will be randomly assigned to one of three groups: two experimental groups receiving PBM therapy at different energy densities (7.5 J/cm2 and 3 J/cm2) and a placebo control group receiving sham treatment with the laser device turned off but mimicking the sounds of therapy. Each participant will have 22 points treated both inside and outside the mouth, with sessions twice a week for 12 weeks (a total of 24 sessions). All groups will use the LAXER mobile health app to support oral health management. Throughout the study, researchers will assess changes in quality of life, xerostomia severity, mouth opening, salivary secretion, and other oral health measures from baseline to 12 weeks after treatment and again at 6 months follow-up. Additional evaluations will include pain thresholds, physical function, mood, and sleep quality. These assessments will help determine the short- and longer-term impacts of PBM therapy combined with digital support on head and neck cancer survivors' well-being and oral health.

Photobiomodulation Therapy Plus M-health in Head and Neck Cancer Patients: LAXER Study