Neoplasms

All Conditions

Mouth and Tooth Diseases

Behaviors and Mental Disorders

Head and Neck Neoplasms

Xerostomia

Salivary Gland Diseases

Mouth Diseases

Stomatognathic Diseases

Quality of Life

The placebo control group will carry out the same protocol used in irradiated patients (including the use of protective goggles) using the same laser device to imitate a real irradiation; however, the device will be turned off and recording of the emission sounds will be used to give the patient the hearing sensation of the PBM therapy.

A total of 22 points will be treated (extraoral and intraoral). 2 sessions per week, for 3 months (24 sessions in total).

Energy density photobiomodulation (7.5)

Sham placebo

Noelia Galiano-Castillo, PhD

Patients with head and neck cancer post-radiotherapy may improve their perceived and amount of saliva after a 3-month Photobiomodulation (PBM) therapy focuses on three main salivary glands (parotid, submandibular and sublingual glands).

The use of PBM therapy in survivors with head and neck cancer may be an effective treatment to improve xerostomia and hyposalivation as side effects of radiotherapy. Although there is some scientific evidence on its benefits during or after radiotherapy, it is not sufficient to establish it as an effective treatment. For these reasons, studies of higher methodological quality such as randomized controlled trials, are needed. This study aims to demonstrate the benefits of PBM therapy on xerostomia and hyposalivation in survivors with head and neck cancer undergone radiotherapy, and whether the effects are maintained after a follow-up period.

Participants who meet the inclusion and exclusion criteria will be randomized to one of the two 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.

Photobiomodulation Therapy in Patients With Head and Neck Cancer Post-Radiotherapy

Pilot Study Evaluating the Impact of a Photobiomodulation Therapy on Xerostomia and Hyposalivation in Patients With Head and Neck Cancer Post-Radiotherapy

Each adverse event is characterized by severity (grade 1 \[mild\] to 5 \[death\]), expectation (expected or unexpected) and potential relationship with participation in our study (unrelated, possibly related, or related to the study) using Common Terminology Criteria for adverse events (version 5.0). Higher scores mean a worse outcome.

Each patient will mark his/her experience after PBM therapy. Higher scores mean a better outcome.

Xerostomia Inventory consists of 11 items, the total score ranges from 11 to 55 points, and represents the severity of chronic xerostomia. Higher scores mean a worse outcome.

Determines the amount of unstimulated saliva (ml) produced in 3 minutes. Higher amount means less hyposalivation.

The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0 assesses overall quality of life. It is a valid questionnaire and widely used in cancer population. High score for functional scales and global health status represents better outcomes. Higher symptom scales/items scores mean a worse outcome. In addition, its specific head and neck module (EORTC QLQ-H\&N35) where higher symptom scales/items scores mean a worse outcome.

Assesses through a Eating Assessment Tool questionnaire (EAT-10). Higher scores mean a worse outcome.

Determine maximum mouth opening (mm) as the inter-incisor distance using a sliding caliper. More distance means better mobility.

Using a digital algometer in C5-C6 joint, upper trapezius, levator scapulae, masseter, temporalis, sternoclavicular joint and the tibialis anterior (distal point). Higher values mean higher pain pressure threshold.

The International Fitness Scale (IFIS) assesses overall fitness, cardio-respiratory, muscular, speed and flexibility dimensions using a 5-point Likert scale ('very poor', 'poor', 'average', 'good' and 'very good'). Higher scores mean a better outcome.

The Spanish version of the Scale for Mood Assessment (EVEA) assesses mood state with a range of 0 to 10. It consists of 4 subscales: sadness-depression, anxiety, anger-hostility and happiness. Higher scores mean a worse outcome.

The Pittsburgh Sleep Quality Index will be used to evaluate the perceived quality of sleep in its Spanish version. Higher scores mean a worse outcome.

The International Physical Activity Questionnaire (IPAQ-SF) is a tool that it will be used to evaluate physical activity. Different types of physical activities will be recorded (walking, moderate intensity activities, and vigorous intensity activities) during the last 7 days. More time means more amount of physical activity.

Using walked distance (m) during 6-minutes walking test. Longer distance means better outcome.

Using time (s) during Test Up and Go (TUG). Less time means less risk of falls.

Universidad de Granada

Principal Investigator

Energy density 7.5 J / cm2 for group PBM_1

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.

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.

Energy density photobiomodulation (3)

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

Maria de la Cabeza Lopez-Garzon, MsC

Elisa Paula Postigo-Martin, MsC

Mario Lozano-Lozano, PhD

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.

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.

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

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).

Safety will be assessed by the occurrence of any AEs using CTCAE version 5.0.

Satisfaction will be registered by a questionnaire previously used in other clinical settings at the end of the intervention.

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.

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.

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.

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

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.

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.

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).

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.

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.

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.

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.

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.

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).

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.

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).

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Photobiomodulation Therapy in Patients With Head and Neck Cancer Post-Radiotherapy	NCT05614843	Head and Neck C... Head and Neck N... Xerostomia	Energy density ... Sham placebo	18 Years - 70 Years	Universidad de Granada
Photobiomodulation Therapy Plus M-health in Head and Neck Cancer Patients: LAXER Study	NCT05106608	Head and Neck C... Head and Neck N... Xerostomia	Energy density ... Energy density ... Sham placebo	18 Years -	Universidad de Granada

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