Clinical trial · Interventional
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
NCT05106608CI-TRIAL-00100071LAXERrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 18, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260918-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Xerostomia | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Energy density photobiomodulation (3) | Device | — | UNRESOLVED |
| Energy density photobiomodulation (7.5) | Device | — | UNRESOLVED |
| Sham placebo | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Group PBM_1
- description
- Energy density 7.5 J / cm2 for group PBM\_1
- interventionNames
- Device: Energy density photobiomodulation (7.5)
- type
- EXPERIMENTAL
- label
- Group PBM_2
- description
- Energy density 3 J / cm2 for group PBM\_2
- interventionNames
- Device: Energy density photobiomodulation (3)
- type
- PLACEBO_COMPARATOR
- label
- Placebo Control
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDLozano-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/s12955-025-02347-1. PMID 40033397
- DERIVEDLopez-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 from chronic xerostomia after radiotherapy: protocol for a three-arm, randomised, placebo-controlled, double-blinded study. BMJ Open. 2024 Jan 24;14(1):e078068. doi: 10.1136/bmjopen-2023-078068. PMID 38267245