Photobiomodulation Therapy With Mobile Health Support to Improve Oral Health and Quality of Life in Head and Neck Cancer Survivors
Led by Universidad de Granada · Updated on 2026-01-05
60
Participants Needed
1
Research Sites
21 weeks
Total Duration
AI-Summary
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 Jcm2 and 3 Jcm2 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.
CONDITIONS
Brief Title
Photobiomodulation Therapy Plus M-health in Head and Neck Cancer Patients: LAXER Study
Research Team
N
Noelia Galiano-Castillo, PhD
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Men or women aged 18 years or older diagnosed with head and neck cancer
Have chronic xerostomia (dry mouth)
Received radiotherapy in the parotid, submandibular, and/or sublingual salivary glands
Grade 3 oral dryness according to Common Terminology Criteria for Adverse Events version 5.0
Completed medical treatment and are in complete remission
Received medical clearance to participate
At least one month and no more than 36 months have passed since the end of radiotherapy
No recent changes or use of drugs/devices/products to prevent or treat xerostomia for at least two months prior
Able to access mobile applications or live with someone who can
You will not qualify if you...
Patients with cancer metastases
Karnofsky Performance Status Scale score below 60
Contraindications to photobiomodulation therapy such as cardiac arrhythmias, pacemakers, photosensitivity, photosensitizing drugs, or pregnancy
Other comorbidities like diabetes or polypharmacy
Withdrawal of consent
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 3 months
Participants receive photobiomodulation therapy targeting 22 points (extraoral and intraoral) twice a week for 3 months, totaling 24 sessions. They also use a mobile health application (LAXER) during this period.
2 sessions per week (in-person)
Follow-up
Duration - Up to 3 months after treatment
Participants are monitored for changes in quality of life, oral health, salivary function, functional performance, mood, and sleep quality up to 6 months after treatment ends.
Visits at 12 weeks (post-intervention) and 6 months (follow-up)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Published Research Related To This Trial
Efficacy of photobiomodulation therapy combined with mobile health education in patients with head and neck cancer suffering from chronic xerostomia after radiotherapy: protocol for a three-arm, randomised, placebo-controlled, double-blinded study.
Maria Lopez-Garzon, María Dolores López-Fernández, Alba Maria Ruíz-Martínez...
Reliability of the electronic patient reported outcome measures for assessing xerostomia, dysphagia and quality of life in Spanish patients with head and neck cancer: a randomised crossover design.
Mario Lozano-Lozano, Maria Lopez-Garzon, Paula Cuadrado-Guerrero...