Photobiomodulation Therapy Plus M-health in Head and Neck Cancer Patients: LAXER Study
Photobiomodulation Therapy With M-health Tool for the Management of Oral Health and Quality of Life in Head and Neck Cancer Patients: LAXER Study
Universidad de Granada
60 participants
Jul 13, 2022
INTERVENTIONAL
Conditions
Summary
The Photobiomodulation therapy could have positive effects on quality of life and oral health in head and neck cancer survivors post-radiotherapy. The improvement in quality of life will be maintained after a follow-up period.
Eligibility
Inclusion Criteria9
- men or women aged 18 years or older and were diagnosed with HNC.
- chronic xerostomia.
- received RT in the parotid, submandibular and/or sublingual salivary glands.
- grade 3 oral dryness according to the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE).
- medical treatment completed and in complete remission.
- received medical clearance for participation in this study.
- at least one month passed since the end of RT to avoid the possible presence of oral mucositis and/or radiodermatitis, which limits adherence to treatment and maximum 36 months.
- no history of drugs/devices/products (pilocarpine, cevimeline, amifostine, oral devices, humidifiers, or herbs) to prevent or treat xerostomia prior to study inclusion or no change in their use (no change in type or dose) for two months prior to study inclusion.
- and able to access mobile applications or living with someone who has this ability.
Exclusion Criteria5
- patients with metastases.
- a score \<60 on the Karnofsky Performance Status Scale.
- contraindications to receiving PBM therapy (e.g., cardiac arrhythmias, pacemakers, photosensitivity, drugs with photosensitizing action, and pregnancy).
- other comorbidities such as diabetes and polypharmacy.
- and retraction of the declaration of consent.
Interventions
A total of 22 points will be treated (extraoral and intraoral). 2 sessions per week, for 3 months (24 sessions in total). In addition, a mobile health application (LAXER) will be provided.
A total of 22 points will be treated (extraoral and intraoral). 2 sessions per week, for 3 months (24 sessions in total). In addition, a mobile health application (LAXER) will be provided.
In addition, a mobile health application (LAXER) will be provided.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05106608