RecruitingNot ApplicableNCT05106608

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


Sponsor

Universidad de Granada

Enrollment

60 participants

Start Date

Jul 13, 2022

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining light therapy (photobiomodulation — a specific wavelength of light applied to the mouth) with a mobile health app can reduce severe dry mouth in people who had radiation treatment for head and neck cancer. **You may be eligible if...** - You are 18 years or older and have been diagnosed with head and neck cancer - You completed radiation therapy that included the salivary glands, 1 to 36 months ago - You have severe, ongoing dry mouth (grade 3 on a standard toxicity scale) - Your cancer treatment has finished and you are in complete remission - You have received medical clearance to participate **You may NOT be eligible if...** - You are still actively receiving cancer treatment - Your dry mouth is less severe than grade 3 - You had prior adverse reactions to the devices or treatments being studied - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEEnergy 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.

DEVICEEnergy 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.

DEVICESham placebo

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


Locations(1)

Faculty of Health Sciences

Granada, Granada, Spain

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NCT05106608


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