Clinical Trial Finder

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.

Many experts advocate the use of Photobiomodulation (PBM) therapy in patients with cancer and demand studies of higher methodological quality such as randomized controlled clinical trials. However, there is no consensus on the most effective dosimetry that allows us to establish an effective and safe approach to treat radiotherapy-induced xerostomia in head and neck cancer survivors. Finally, recent reviews highlight the importance of determining whether or not the effects of Photobiomodulation therapy are maintained after a follow-up period.

Arms

Experimental: Group PBM_1

Energy density 7.5 J / cm2 for group PBM_1

Experimental: Group PBM_2

Energy density 3 J / cm2 for group PBM_2

Placebo Comparator: Placebo Control

The placebo control group will carry out the same protocol used in irradiated patients (including the use of protective glasses) using the same laser device to imitate a real irradiation; however, the device will be turned off and a recording of the emission sounds will be used to give the patient the hearing sensation of the laser therapy.

Interventions

Device: - Energy density photobiomodulation (7.5)

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.

Device: - Energy density photobiomodulation (3)

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.

Device: - Sham placebo

In addition, a mobile health application (LAXER) will be provided.