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

September 14, 2026 updated by: Noelia Galiano-Castillo, Universidad de Granada

Photobiomodulation Therapy With M-health Tool for the Management of Oral Health and Quality of Life in Head and Neck Cancer Patients: LAXER Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
      • Granada, Spain, 18070
        • Recruiting
        • Faculty of Health Sciences
        • Sub-Investigator:
          • Maria de la Cabeza Lopez-Garzon, MsC
        • Contact:
          • Noelia Galiano-Castillo, PhD
        • Sub-Investigator:
          • Mario Lozano-Lozano, PhD
        • Sub-Investigator:
          • Elisa Paula Postigo-Martin, MsC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group PBM_1
Energy density 7.5 J / cm2 for group PBM_1
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.
Experimental: Group PBM_2
Energy density 3 J / cm2 for group PBM_2
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.
Placebo Comparator: Placebo Control
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
In addition, a mobile health application (LAXER) will be provided.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
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.
Time Frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
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.
Time Frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
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.
Time Frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
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.
Time Frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
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).
Time Frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
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.
Time Frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
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.
Time Frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
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.
Time Frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pressure pain threshold.
Time Frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
An electronic algometer (SENSEBox System, Somedic AB, Sösdala, SE) will be used to assess pain at 7 body sites bilaterally: the C5-C6 joint, upper trapezius, elevator scapulae, masseter, temporalis, sternoclavicular joint and tibialis anterior distal point. The mean of the three measurements will be considered.
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).
The 6-minute walk test (6MWT) will be used; the maximum walked distance (meters) that patients are able to walk in a 30-meter linear corridor will be quantified. A longer distance indicates better 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.
Time Frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
The timed up-and-go (TUG) test will be used; patients sit back in a chair and walk toward a cone located 3 meters away as quickly as possible. The time (seconds) needed will be registered 2 times, with a shorter time indicating better mobility.
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).
The International Fitness Scale (IFIS) assesses overall fitness, cardio-respiratory fitness, muscular strength, speed/agility and flexibility dimensions, using a 5-point Likert scale (1=very poor, 2=poor, 3=average, 4=good, 5=very good).
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).
The International Physical Activity Questionnaire Short Form (IPAQ-SF), a self-reported validated questionnaire in patients with cancer that records the activities of the previous 7 days according to intensity level.
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).
The Spanish version of the Scale for Mood Assessment (EVEA) will also be used and comprises 4 subscales with good reliability (sadness-depression, anxiety, anger-hostility and happiness); the items range from 0 to 10 (0=nothing, 10=much).
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).
Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI), a validated questionnaire that includes 19 self-related questions ranging from 0 to 3. The total score ranges from 0 to 21, and a lower score indicates better quality of sleep.
Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety and adverse events (AEs).
Time Frame: 12 weeks (postintervention)
Safety will be assessed by the occurrence of any AEs using CTCAE version 5.0.
12 weeks (postintervention)
Satisfaction questionnaire.
Time Frame: 12 weeks (postintervention)
Satisfaction will be registered by a questionnaire previously used in other clinical settings at the end of the intervention.
12 weeks (postintervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad de Granada

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Noelia Galiano-Castillo, PhD, Universidad de Granada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 13, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 10, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 4, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PBM_CANCER21
  • PI-0187-2021 (Other Grant/Funding Number: Conserjeria de Salud y Familias (Junta de Andalucía))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be available upon reasonable request. IPD that underlie the results reported in the future article/s, after deidentification (text, tables, figures, and appendices).

IPD Sharing Time Frame

Beginning 3 months and ending 5 years following article publication.

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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