Photobiomodulation Therapy Plus M-health in Head and Neck Cancer Patients: LAXER Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversidad de Granada
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Energy density photobiomodulation (7.5)
DeviceA 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)
DeviceA 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
DeviceIn addition, a mobile health application (LAXER) will be provided.
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Group PBM_1Experimental treatment 1 intervention
Group B: Group PBM_2Experimental treatment 1 intervention
Group C: Placebo ControlPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).2
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).3
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).4
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).Secondary outcomes
1
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).2
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).3
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).4
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).Other outcomes
1
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)2
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)Sponsors and contacts
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Source ClinicalTrials.gov