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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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.

Locations
Other Locations
Spain
Faculty of Health Sciences
RECRUITING
Granada
Contact Information
Primary
Noelia Galiano-Castillo, PhD
noeliagaliano@ugr.es
699197690
Time Frame
Start Date: 2022-07-13
Estimated Completion Date: 2026-07
Participants
Target number of participants: 60
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Universidad de Granada

This content was sourced from clinicaltrials.gov