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

University of Granada (UGR)

Status: Enrolling

Conditions: Xerostomia; Head and Neck Neoplasms; Head and Neck Cancer

Treatments: Device: Energy density photobiomodulation (7.5); Device: Sham placebo; Device: Energy density photobiomodulation (3)

Study type: Interventional

Funder types: Other

Identifiers

NCT05106608

PI-0187-2021 (Other Grant/Funding Number)

PBM_CANCER21

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups, including a placebo group

Group PBM_1

Experimental group

Description:

Energy density 7.5 J / cm2 for group PBM\_1

Treatment:

Device: Energy density photobiomodulation (7.5)

Group PBM_2

Experimental group

Description:

Energy density 3 J / cm2 for group PBM\_2

Treatment:

Device: Energy density photobiomodulation (3)

Placebo Control

Placebo Comparator group

Description:

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.

Treatment:

Device: Sham placebo