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

Not Applicable

Recruiting

• Conditions: Head and Neck Cancer; Head and Neck Neoplasms; Xerostomia
• Interventions: Device: Sham placebo; Device: Energy density photobiomodulation (7.5); Device: Energy density photobiomodulation (3)

• Registration Number: NCT05106608
• Lead Sponsor: Universidad de Granada

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.

Study Timeline

• Study First Submitted: 2021-10-10
• Study First Submitted QC: 2021-10-22
• Study First Posted: 2021-11-04
• Study Start: 2022-07-13
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30
• Primary Completion: 2025-12
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Control	Sham placebo	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.
Group PBM_1	Energy density photobiomodulation (7.5)	Energy density 7.5 J / cm2 for group PBM_1
Group PBM_2	Energy density photobiomodulation (3)	Energy density 3 J / cm2 for group PBM_2

Primary Outcome Measures

Name	Time	Method
General and specific quality of life.	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.
Oral Health. Severity of xerostomia.	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.
Oral Health. Dysphagia.	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.
Oral Health. Clinical physical findings (dryness in the mouth).	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.
Oral Health. Perceived xerostomia.	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).
Oral Health. Degree of mouth opening.	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.
Oral Health. Regional oral dryness.	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).
Salivary secretion.	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.
Salivary gland ultrasound assessment.	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.

Secondary Outcome Measures

Name	Time	Method
Mood.	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).
Functional Performance. Functional capacity.	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.
Functional Performance. Mobility/fall risk.	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.
Functional Performance. Physical activity level.	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.
Pressure pain threshold.	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.
Functional Performance. Perceived fitness status.	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).
Sleep quality.	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.

Trial Locations

Locations (1)

Faculty of Health Sciences; 🇪🇸 Granada, Spain