Clinical trial NCT05106608: Photobiomodulation Therapy Plus M-health in Head and Neck Cancer Patients: LAXER Study
Official title: Photobiomodulation Therapy With M-health Tool for the Management of Oral Health and Quality of Life in Head and Neck Cancer Patients: LAXER Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Cancer
Head and Neck Neoplasms
Xerostomia
Keywords: Quality of Life
Neoplasms
Xerostomia
Low-Level Light Therapy
Telemedicine
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2021-11-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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.

Primary outcomes:
measure: General and specific quality of life.
timeFrame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
measure: Oral Health. Severity of xerostomia.
timeFrame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
measure: Oral Health. Dysphagia.
timeFrame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
measure: Oral Health. Perceived xerostomia.
timeFrame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
measure: Oral Health. Degree of mouth opening.
timeFrame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
measure: Oral Health. Clinical physical findings (dryness in the mouth).
timeFrame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
measure: Oral Health. Regional oral dryness.
timeFrame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
measure: Salivary secretion.
timeFrame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
measure: Salivary gland ultrasound assessment.
timeFrame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
Secondary outcomes:
measure: Pressure pain threshold.
timeFrame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
measure: Functional Performance. Functional capacity.
timeFrame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
measure: Functional Performance. Mobility/fall risk.
timeFrame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
measure: Functional Performance. Perceived fitness status.
timeFrame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
measure: Functional Performance. Physical activity level.
timeFrame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
measure: Mood.
timeFrame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
measure: Sleep quality.
timeFrame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
Other outcomes:
measure: Safety and adverse events (AEs).
timeFrame: 12 weeks (postintervention)
measure: Satisfaction questionnaire.
timeFrame: 12 weeks (postintervention)
Locations:
city: Granada
country: Spain
facility: Faculty of Health Sciences
Study officials:
affiliation: Universidad de Granada
name: Noelia Galiano-Castillo, PhD
role: PRINCIPAL_INVESTIGATOR
References: