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Recruiting NCT05106608

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

No phase Interventional Head and Neck Cancer Head and Neck Neoplasms Xerostomia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Energy density photobiomodulation (7.5), Energy density photobiomodulation (3), Sham placebo.
Who it may be relevant to
Registry conditions: Head and Neck Cancer, Head and Neck Neoplasms, Xerostomia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

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.

Primary outcome measures

  • General and specific quality of life. [Time frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).]
  • Oral Health. Severity of xerostomia. [Time frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).]
  • Oral Health. Dysphagia. [Time frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).]
  • Oral Health. Perceived xerostomia. [Time frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).]
  • Oral Health. Degree of mouth opening. [Time frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).]
  • Oral Health. Clinical physical findings (dryness in the mouth). [Time frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).]
  • Oral Health. Regional oral dryness. [Time frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).]
  • Salivary secretion. [Time frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).]
  • Salivary gland ultrasound assessment. [Time frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).]
Secondary outcome measures (7)
  • Pressure pain threshold. [Time frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).]
  • Functional Performance. Functional capacity. [Time frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).]
  • Functional Performance. Mobility/fall risk. [Time frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).]
  • Functional Performance. Perceived fitness status. [Time frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).]
  • Functional Performance. Physical activity level. [Time frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).]
  • Mood. [Time frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).]
  • Sleep quality. [Time frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Spain · 1 center
  • Faculty of Health Sciences — Granada

Publications

  • Lozano-Lozano M, Lopez-Garzon M, Cuadrado-Guerrero P, Postigo-Martin P, Fernandez-Lao C, Tovar-Martin I, Galiano-Castillo N. Reliability of the electronic patient reported outcome measures for assessing xerostomia, dysphagia and quality of life in Spanish patients with head and neck cancer: a randomised crossover design. Health Qual Life Outcomes. 2025 Mar 3;23(1):19. doi: 10.1186/s12955-025-02347 PMID 40033397
  • Lopez-Garzon M, Lopez-Fernandez MD, Ruiz-Martinez AM, Galvan-Banqueri P, Lozano-Lozano M, Tovar-Martin I, Postigo-Martin P, Ariza-Vega P, Artacho-Cordon F, Fernandez-Lao C, Cantarero-Villanueva I, Fernandez-Gualda MA, Arroyo-Morales M, Ruiz-Villaverde R, Galiano-Castillo N. Efficacy of photobiomodulation therapy combined with mobile health education in patients with head and neck cancer suffering PMID 38267245

Identifiers

NCT: NCT05106608 · PBM_CANCER21 · PI-0187-2021

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗