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

NCT05106608 | Recruiting

• 2 other identifiers: PBM_CANCER21PI-0187-2021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Neoplasms; Xerostomia; Head and Neck Cancer

Keywords

Quality of Life; Neoplasms; Xerostomia; Low-Level Light Therapy; Telemedicine

Outcome Measures

Primary Outcomes (9)

• General and specific quality of life.

  The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0 comprises 30 items on 5 functional scales, 3 symptom scales, 6 single items and a global health scale measured by a 4-point Likert scale with a total score ranging from 0 to 100. Higher scores on the functional and global health scales indicate better functioning or QoL, respectively, but higher scores on the symptom scales or single items indicate a high level of symptoms. In addition, the specific head and neck module (EORTC QLQ-H\&N35) will be used; this module comprises 35 items on 7 multi-item scales and 11 single items scored from 0 to 100. Higher scores indicate more symptoms.

  Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).

• Oral Health. Severity of xerostomia.

  Xerostomia Inventory consists of 11 items (score range 1-5) with a total score ranging from 11 to 55 points to rate the severity of chronic xerostomia. A higher score indicates more severe xerostomia.

  Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).

• Oral Health. Dysphagia.

  Eating Assessment Tool questionnaire (EAT-10) consists of 10 items related to swallowing difficulties (score range 0-4, 0=no problem, 4=severe problem), with a total score of 3 or higher indicating dysphagia.

  Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).

• Oral Health. Perceived xerostomia.

  A numeric visual analog scale (VAS) will be used with with a grade ranging from 0 (no symptoms) to 10 (the worst possible symptoms).

  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.

  The degree of mouth opening will be determined by the range of motion (ROM) using a sliding caliper, which will measure the maximal interincisal distance in millimeters.

  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).

  A total of 10 examples of clinical physical findings where each one represents a feature of dryness in the mouth will be administered through the Clinical Oral Dryness Score (CODS). A score of 2 or more indicates significant oral dryness.

  Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).

• Oral Health. Regional oral dryness.

  Regional Oral Dryness Inventory (RODI) quantifies the severity of dryness at 9 different locations in the oral cavity and is represented by 9 illustrations. Patients will indicate the severity of perceived oral dryness using a 5-point Likert scale (1=none, 5=severe).

  Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).

• Salivary secretion.

  The 5-min unstimulated and 5-min stimulated salivary flow rates (SFRs) will be calculated (ml/min) and the volume of each sample will be also calculated (in microlitres). Samples from unstimulated saliva will be used to analyse salivary biomarkers, such as proteins (e.g., antibodies), calcium concentration and pH, using commercial kits.

  Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).

• Salivary gland ultrasound assessment.

  The morphology of the parotid and submandibular glands will be assessed using 2D echography (Samsung HM70A echograph) to quantify changes in size in three dimensions.

  Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).

Secondary Outcomes (7)

• Pressure pain threshold.

  Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).

• Functional Performance. Functional capacity.

  Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).

• Functional Performance. Mobility/fall risk.

  Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).

• Functional Performance. Perceived fitness status.

  Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).

• Functional Performance. Physical activity level.

  Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).

Other Outcomes (2)

• Safety and adverse events (AEs).

  12 weeks (postintervention)

• Satisfaction questionnaire.

  12 weeks (postintervention)

Study Arms (3)

Group PBM_1

EXPERIMENTAL

Energy density 7.5 J / cm2 for group PBM\_1

Device: Energy density photobiomodulation (7.5)

Group PBM_2

EXPERIMENTAL

Energy density 3 J / cm2 for group PBM\_2

Device: Energy density photobiomodulation (3)

Placebo Control

PLACEBO COMPARATOR

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.

Device: Sham placebo

Interventions

Energy density photobiomodulation (3) DEVICE

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.

Group PBM_2

Sham placebo DEVICE

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

Placebo Control

Energy density photobiomodulation (7.5) DEVICE

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.

Group PBM_1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• and able to access mobile applications or living with someone who has this ability.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

Faculty of Health Sciences

Granada, Granada, 18070, Spain

RECRUITING

Related Publications (2)

• 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/s12955-025-02347-1.

  PMID: 40033397 DERIVED

• 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 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 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms; Xerostomia; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Noelia Galiano-Castillo, PhD

  Universidad de Granada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Noelia Galiano-Castillo, PhD

CONTACT

699197690; noeliagaliano@ugr.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants who meet the inclusion and exclusion criteria will be randomized to one of the three study groups using a random number generation program (www.randomizer.org). The randomization sequence will be prepared by a member external to the investigation to respect the masking in terms of randomization of the participants, thus reducing the risk of bias during the evaluations. Therefore both patients and evaluator will be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: October 10, 2021
• First Posted: November 4, 2021
• Study Start: July 13, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

ES (1)