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

Launched by UNIVERSIDAD DE GRANADA · Oct 22, 2021

Keywords

ClinConnect Summary

The LAXER Study is looking at a treatment called Photobiomodulation (PBM) therapy to see how it can help improve the quality of life and oral health for people who have survived head and neck cancer, especially those dealing with chronic dry mouth (xerostomia) after receiving radiation therapy. This study aims to find out if PBM therapy, combined with mobile health support, can make a lasting positive difference in the lives of these patients.

To participate in this study, individuals need to be at least 18 years old and have been diagnosed with head and neck cancer. They should have experienced severe dry mouth following radiation to certain salivary glands and must be in complete remission from their cancer. It's also important that they have received medical clearance to join the study and can use mobile apps. Participants will receive treatment and can expect to see improvements in their oral health and overall well-being. This study is currently recruiting participants and aims to help those suffering from the effects of their cancer treatment.

Gender

ALL

Eligibility criteria

• Patients will be included in the study if they meet the following inclusion criteria:
• • 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.
• The exclusion criteria will be as follows:
• • 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.