An interventional study of Energy density photobiomodulation (7.5) and Energy density photobiomodulation (3) in Head and Neck Cancer, Head and Neck Neoplasms and Xerostomia, sponsored by Universidad de Granada. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Universidad de Granada · Not applicable, Interventional, and Treatment
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.
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.
2,710 studies on the registry are indexed under Head and Neck Neoplasms; 594 are open to participants now.
This study's planned enrollment of 60 is above the median of 46 across 2,032 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Universidad de Granada is the lead sponsor of 246 studies on the registry; 43 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients will be included in the study if they meet the following inclusion criteria:
The exclusion criteria will be as follows:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Energy density 7.5 J / cm2 for group PBM\_1
Device: Energy density photobiomodulation (7.5)
Energy density 3 J / cm2 for group PBM\_2
Device: Energy density photobiomodulation (3)
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
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.
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.
In addition, a mobile health application (LAXER) will be provided.
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.
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.
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.
Time frame: 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.
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.
A numeric visual analog scale (VAS) will be used with with a grade ranging from 0 (no symptoms) to 10 (the worst possible symptoms).
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.
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.
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).
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.
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.
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).
Time frame: 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.
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.
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.
Time frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
Pressure pain threshold.
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.
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.
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.
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.
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.
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.
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).
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.
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.
Time frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
Mood.
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).
Time frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
Sleep quality.
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.
Time frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
Safety and adverse events (AEs).
Safety will be assessed by the occurrence of any AEs using CTCAE version 5.0.
Time frame: 12 weeks (postintervention)
Satisfaction questionnaire.
Satisfaction will be registered by a questionnaire previously used in other clinical settings at the end of the intervention.
Time frame: 12 weeks (postintervention)
Plan to share: Yes — 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).
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Beginning 3 months and ending 5 years following article publication.
Access criteria: Researchers who provide a methodologically sound proposal.
Started Jul 2022 (actual). Primary completion is estimated for Dec 2027, 65 months after the start.
Of 437 non-industry interventional studies with no phase under Head and Neck Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 71. This study's planned 65 months is above that.
Counting every sponsor, half of 455 studies reached it within 32 months; a quarter within 18 and three quarters within 70.
How these figures are worked out, and which studies are left out of them.
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