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

Head and Neck Cancer Clinical Trial

— LAXER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05106608
• Other study ID #: PBM_CANCER21
• Secondary ID: PI-0187-2021
• Status: Recruiting
• Phase: N/A
• Start date: July 13, 2022
• Est. completion date: July 2025

Study information

• Verified date: January 2024
• Source: Universidad de Granada
• Contact: Noelia Galiano-Castillo, PhD
• Phone: 699197690
• Email: noeliagaliano[@]ugr.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Xerostomia

Intervention

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

Locations

Country	Name	City	State
Spain	Faculty of Health Sciences	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety and adverse events (AEs).	Safety will be assessed by the occurrence of any AEs using CTCAE version 5.0.	12 weeks (postintervention)
Other	Satisfaction questionnaire.	Satisfaction will be registered by a questionnaire previously used in other clinical settings at the end of the intervention.	12 weeks (postintervention)
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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	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.	Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
Secondary	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.	Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
Secondary	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.	Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
Secondary	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).	Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
Secondary	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.	Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
Secondary	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).	Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
Secondary	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.	Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).